Surgeons in surge — the versatility of the acute care surgeon: outcomes of COVID-19 ICU patients in a community hospital where all ICU patients are managed by surgical intensivists

BackgroundReported characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit (ICU) are widely disparate with varying mortality rates. No literature describes outcomes in ICU patients with COVID-19 managed by an acute care surgery (ACS) division. Our ACS division manages all ICU patients at a community hospital in New Jersey. When that hospital was overwhelmed and in crisis secondary to COVID-19, we sought to describe outcomes for all patients with COVID-19 admitted to our closed ICU managed by the ACS division.MethodsThis was a prospective case series of the first 120 consecutive patients with COVID-19 admitted on March 14 to May 10, 2020. Final follow-up was May 27, 2020. Patients discharged from the ICU or who died were included. Patients still admitted to the ICU at final follow-up were excluded.ResultsOne hundred and twenty patients were included (median age 64 years (range 25–89), 66.7% men). The most common comorbidities were hypertension (75; 62.5%), obesity (61; 50.8%), and diabetes (50; 41.7%). One hundred and thirteen (94%) developed acute respiratory distress syndrome, 89 (74.2%) had shock, and 76 (63.3%) experienced acute kidney injury. One hundred (83.3%) required invasive mechanical ventilation (IMV). Median ICU length of stay (LOS) was 8.5 days (IQR 9), hospital LOS was 14.5 days (IQR 13). Mortality for all ICU patients with COVID-19 was 53.3% and 62% for IMV patients.ConclusionsThis is the first report of patients with COVID-19 admitted to a community hospital ICU managed by an ACS division who also provided all surge care. Mortality of critically ill patients with COVID-19 admitted to an overwhelmed hospital in crisis may not be as high as initially thought based on prior reports. While COVID-19 is a non-surgical disease, ACS divisions have the capability of successfully caring for both surgical and medical critically ill patients, thus providing versatility in times of crisis.Level of evidenceLevel V.

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Acute Care Surgery Service Is Essential During a Nonsurgical Catastrophic Event, the COVID-19 Pandemic

The American Surgeon ◽

10.1177/0003134820972084 ◽

2020 ◽

pp. 000313482097208

Author(s):

Nikolay Bugaev ◽

Horacio M. Hojman ◽

Janis L. Breeze ◽

Stanley A. Nasraway ◽

Sandra S. Arabian ◽

...

Keyword(s):

Critically Ill ◽

Acute Care ◽

Critically Ill Patients ◽

Medical Center ◽

Academic Medical Center ◽

Clinical Severity ◽

Acute Care Surgery ◽

Emergency General Surgery ◽

Care Surgery ◽

Nonsurgical Patients

Background The role of an acute care surgery (ACS) service during the COVID-19 pandemic is not well established. Methods A retrospective review of the ACS service performance in an urban tertiary academic medical center. The study was performed between January and May 2020. The demographics, clinical characteristics, and outcomes of patients treated by the ACS service 2 months prior to the COVID surge (pre-COVID group) and during the first 2 months of the COVID-19 pandemic (surge group) were compared. Results Trauma and emergency general surgery volumes decreased during the surge by 38% and 57%, respectively; but there was a 64% increase in critically ill patients. The proportion of patients in the Department of Surgery treated by the ACS service increased from 40% pre-COVID to 67% during the surge. The ACS service performed 32% and 57% of all surgical cases in the Department of Surgery during the pre-COVID and surge periods, respectively. The ACS service managed 23% of all critically ill patients in the institution during the surge. Critically ill patients with and without confirmed COVID-19 infection treated by ACS and non-ACS intensive care units during the surge did not differ in demographics, indicators of clinical severity, or hospital mortality:13.4% vs. 13.5% ( P = .99) for all critically ill patients; and 13.9% vs. 27.4% ( P = .12) for COVID-19 critically ill patients. Conclusion Acute care surgery is an “essential” service during the COVID-19 pandemic, capable of managing critically ill nonsurgical patients while maintaining the provision of trauma and emergent surgical services.

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Clinical characteristics and outcomes of critically ill patients with COVID-19 in a tertiary community hospital in upstate New York

10.1101/2020.06.18.20135046 ◽

2020 ◽

Author(s):

Jyotirmayee Lenka ◽

Mamta S. Chhabria ◽

Naman Sharma ◽

Bryan E-Xin Tan ◽

Leela Krishna Teja Boppana ◽

...

Keyword(s):

New York ◽

Critically Ill ◽

Critically Ill Patients ◽

Community Hospital ◽

Invasive Mechanical Ventilation ◽

Length Of Hospital Stay ◽

Duration Of Symptoms ◽

Upstate New York ◽

Treatment Data

AbstractBackgroundThere are limited reports describing critically ill COVID-19 patients in New York.MethodsWe conducted a retrospective analysis of 32 adult critically ill patients admitted to a tertiary community hospital in upstate NY, between March 14th and April 12th, 2020. We collected demographic, laboratory, ventilator, and treatment data, which were analyzed and clinical outcomes tabulated.Results32 patients admitted to the ICU were included, with mean (±SD) follow-up duration 21 ± 7 days. Mean (±SD) age was 62.2 ± 11.2 years, and 62.5% were men. 27 (84.4%) of patients had one or more medical co-morbidities and 50% of the patients were current or former smokers. The mean (±SD) duration of symptoms was 6.6 (±4.4) days before presentation, with cough (81.3%), dyspnea (68.7%), and fever (65.6%) being most common. 23 (71.9%) patients received invasive mechanical ventilation. 5 (15.6%) had died, 11 (34.4%) had been discharged home, and 16 (50%) remained hospitalized, 8 (25%) of which were still in ICU. Mean (±SD) length of ICU stay was 10.2 (±7.7) days, and mean (±SD) length of hospital stay was 14.8 (±7.7) days.ConclusionMajority of patients were of older age and with medical co-morbidities. With adequate resource utilization, mortality of critically ill COVID-19 patients may not be as high as previously suggested.

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Low albumin levels are associated with poorer outcomes in a case series of COVID-19 patients in Spain: a retrospective cohort study

10.1101/2020.05.07.20094987 ◽

2020 ◽

Cited By ~ 2

Author(s):

Roberto de la Rica ◽

Marcio Borges ◽

María Aranda ◽

Alberto del Castillo ◽

Antonia Socias ◽

...

Keyword(s):

Disease Severity ◽

Critically Ill ◽

Critically Ill Patients ◽

Case Series ◽

Hospitalized Patients ◽

University Hospital ◽

Limited Information ◽

Icu Patients ◽

Epidemiological Features ◽

Initial Symptoms

ABSTRACTOBJECTIVETo describe the clinical characteristics and epidemiological features of severe (non-ICU) and critically patients (ICU) with COVID-19 at triage, prior hospitalization, in one of the main hospitals in The Balearic Islands health care system.DESIGNRetrospective observational studySETTINGSon Llatzer University Hospital in Palma de Mallorca (Spain)PARTICIPANTSAmong a cohort of 52 hospitalized patients as of 31 March 2020, 48 with complete demographic information and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test, were analyzed. Data were collected between March 15th, 2020, and March 31th 2020, inclusive of these dates.MAIN OUTCOMESClinical, vital signs and routine laboratory outcomes at the time of hospitalization, including symptoms reported prior to hospitalization. Demographics and baseline comorbidities were also collected. Mortality was reported at the end of the study.RESULTS48 patients (27 non-ICU and 21 ICU) resident in Mallorca, Spain (mean age, 66 years, [range, 33-88 years]; 67% males) with positive SARS-CoV-2 infection were analyzed. There were no differences in age or sex among groups (p >.05). Initial symptoms included fever (100%), coughing (85%), dyspnea (76%), diarrhea (42%) and asthenia (21%). The majority of patients in this case series were hospitalized because of low SpO2 (SpO2 below 90%) and presentation of bilateral pneumonia (94%) at triage. ICU patients had a higher prevalence of dyspnea compared to non-ICU patients (95% vs 61%, p = .022). Acute respiratory syndrome (ARDS) was presented in 100% of the ICU-patients. All the patients included in the study required oxygen therapy. ICU-patients had lymphopenia as well as hypoalbuminemia. Inflammatory markers such as lactate dehydrogenase (LDH), C-reactive protein (CRP), and procalcitonin were significantly higher in ICU patients compared to non-ICU (p < .001).Lower albumin levels were associated with poor prognosis measured as longer hospital length (r= −0.472, p <.001) and mortality (r= −0.424, p=.003). Interestingly we also found, that MCV was lower among of those patients who died (p=.0002). As of April 28, 2020, 10 patients (8 ICU and 2 non-ICU) had died (21% mortality) and while 100% of the non-ICU patients had been discharged, 33% of ICU patients still remained hospitalized (5 in ICU and 2 had been transferred to ward).CONCLUSIONCritically ill patients with COVID-19 present lymphopenia, hypoalbuminemia as well high levels of inflammation. Lower levels of albumin were associated with poorer outcomes in COVID-19 patients. Albumin might be of importance because of its association with disease severity in patients infected with SARS-CoV-2.WHAT IS ALREADY KNOWN IN THIS TOPICSpain has been hit particularly hard by the pandemic. By the time that this manuscript was written more than 25.000 deaths related to COVID-19 have been confirmed. There is limited information available describing the clinical and epidemiological features of Spanish patients requiring hospitalization for COVID-19. Also, it is important to know the characteristics of the hospitalized patients who become critically illWHAT THIS STUDY ADDSThis small case series provides the first steps towards a comprehensive clinical characterization of severe and critical COVID-19 adult patients in Spain. The overall mortality in our patients was 21%. To our knowledge this is the first report with reporting these features in Spain. At triage the majority of patients had lower SpO2 (<90%) and bilateral pneumonia. The most common comorbidities were hypertension (70%), dyslipidemia (62%) and cardiovascular disease (30%). Critically ill patients present hypoalbuminemia and lymphopenia, as well as higher levels of inflammation. Albumin might be of importance because of its association with disease severity and mortality in patients infected with SARS-CoV-2.

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Clinical Course and Outcomes of Severe Covid-19: A National Scale Study

Journal of Clinical Medicine ◽

10.3390/jcm9072282 ◽

2020 ◽

Vol 9 (7) ◽

pp. 2282 ◽

Cited By ~ 2

Author(s):

Moran Amit ◽

Alex Sorkin ◽

Jacob Chen ◽

Barak Cohen ◽

Dana Karol ◽

...

Keyword(s):

Critically Ill ◽

Critically Ill Patients ◽

Secondary Infection ◽

Invasive Mechanical Ventilation ◽

Multivariable Analysis ◽

Case Series ◽

Government Officials ◽

Multivariable Regression Model ◽

Multivariable Regression ◽

Overall Mortality

Knowledge of the outcomes of critically ill patients is crucial for health and government officials who are planning how to address local outbreaks. The factors associated with outcomes of critically ill patients with coronavirus disease 2019 (Covid-19) who required treatment in an intensive care unit (ICU) are yet to be determined. Methods: This was a retrospective registry-based case series of patients with laboratory-confirmed SARS-CoV-2 who were referred for ICU admission and treated in the ICUs of the 13 participating centers in Israel between 5 March and 27 April 2020. Demographic and clinical data including clinical management were collected and subjected to a multivariable analysis; primary outcome was mortality. Results: This study included 156 patients (median age = 72 years (range = 22–97 years)); 69% (108 of 156) were male. Eighty-nine percent (139 of 156) of patients had at least one comorbidity. One hundred three patients (66%) required invasive mechanical ventilation. As of 8 May 2020, the median length of stay in the ICU was 10 days (range = 0–37 days). The overall mortality rate was 56%; a multivariable regression model revealed that increasing age (OR = 1.08 for each year of age, 95%CI = 1.03–1.13), the presence of sepsis (OR = 1.08 for each year of age, 95%CI = 1.03–1.13), and a shorter ICU stay(OR = 0.90 for each day, 95% CI = 0.84–0.96) were independent prognostic factors. Conclusions: In our case series, we found lower mortality rates than those in exhausted health systems. The results of our multivariable model suggest that further evaluation is needed of antiviral and antibacterial agents in the treatment of sepsis and secondary infection.

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Implementation of an Acute Care Surgery Service in a Community Hospital: Impact on Hospital Efficiency and Patient Outcomes

The American Surgeon ◽

10.1177/000313481608200128 ◽

2016 ◽

Vol 82 (1) ◽

pp. 79-84 ◽

Cited By ~ 6

Author(s):

Michael Kalina

Keyword(s):

Length Of Stay ◽

Patient Care ◽

Acute Care ◽

Patient Outcomes ◽

Community Hospital ◽

Hospital Efficiency ◽

Hospital Charges ◽

Acute Care Surgery ◽

Health Evaluation ◽

Care Surgery

A service led by acute care surgeons managing trauma, critically ill surgical, and emergency general surgery patients via an acute care surgery model of patient care improves hospital efficiency and patient outcomes at university-affiliated hospitals and American College of Surgeons–verified trauma centers. Our goal was to determine whether an acute care surgeon led service, entitled the Surgical Trauma and Acute Resuscitative Service (STARS) that implemented an acute care surgery model of patient care, could improve hospital efficiency and patient outcomes at a community hospital. A total of 492 patient charts were reviewed, which included 230 before the implementation of the STARS [pre-STARS (control)] and 262 after the implementation of the STARS [post-STARS (study)]. Demographics included age, gender, Acute Physiology and Chronic Health Evaluation 2 score, and medical comorbidities. Efficiency data included length of stay in emergency department (ED-LOS), length of stay in surgical intensive care unit (SICU-LOS), and length of stay in hospital (H-LOS), and total in hospital charges. Average age was 64.1 + 16.4 years, 255 males (51.83%) and 237 females (48.17%). Average Acute Physiology and Chronic Health Evaluation 2 score was 11.9 + 5.8. No significant differences in demographics were observed. Average decreases in ED-LOS (9.7 + 9.6 hours, pre-STARS versus 6.6 + 4.5 hours, post-STARS), SICU-LOS (5.3 + 9.6 days, pre-STARS versus 3.5 + 4.8 days, post-STARS), H-LOS (12.4 + 12.7 days, pre-STARS versus 11.4 + 11.3 days, post-STARS), and total in hospital charges ($419,602.6 + $519,523.0 pre-STARS to $374,816.7 + $411,935.8 post-STARS) post-STARS. Regression analysis revealed decreased ED-LOS—2.9 hours [ P = 0.17; 95% confidence interval (CI): -7.0, 1.2], SICU-LOS—6.3 days ( P < 0.001; 95% CI: -9.3, -3.2), H-LOS—7.6 days ( P = 0.001; 95% CI: -12.1, -3.1), and 3.4 times greater odds of survival ( P = 0.04; 95% CI: 1.1, 10.7) post-STARS. In conclusion, implementation of the STARS improved hospital efficiency and patient outcomes at a community hospital.

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Urgent Breast-Related Consults Seen by Acute Care Surgery at a Safety Net Hospital

The American Surgeon ◽

10.1177/00031348211068011 ◽

2022 ◽

pp. 000313482110680

Author(s):

Rachel E. Sargent ◽

Morgan Schellenberg ◽

Natthida Owattanapanich ◽

Allen Chen ◽

Eric Chen ◽

...

Keyword(s):

Acute Care ◽

Cancer Diagnosis ◽

Surgical Oncology ◽

Safety Net ◽

Initial Assessment ◽

Acute Care Surgery ◽

Loss To Follow Up ◽

Safety Net Hospital ◽

Care Surgery

Background Classically, urgent breast consults are seen by Breast Surgery or Surgical Oncology (BS/SO). At our safety net hospital, Acute Care Surgery (ACS) performs all urgent surgical consultations, including initial assessment of breast consults with coordinated BS/SO follow-up. The objective was to determine safety of ACS initial assessment of acute breast pathology. Methods All urgent breast-related consultations were included (2016-2019). Demographics, consult indications, and investigations/interventions were captured. Outcomes were compared between patients assessed by ACS versus both ACS and BS/SO at presentation. Results 234 patients met study criteria, with median age 39 years. Patients were primarily Hispanic (82%) women (96%). Most were not seen by BS/SO at presentation (69%), although BS/SO assessment was more frequent among patients ultimately diagnosed with cancer (8% vs 1%, P = .012). No patient had delay >90 days to core biopsy from presentation. Outcomes including time to cancer diagnosis (14 vs 8 days, P = .143) and outpatient BS/SO assessment (16 vs 13 days, P = .528); loss to follow-up (25% vs 21%, P = .414); and ED recidivism (24% vs 18%, P = .274) were comparable between patients seen by ACS versus ACS/BS/SO at index presentation. Conclusion Urgent breast consults at our safety net hospital typically underwent initial assessment by ACS with outpatient evaluation by BS/SO. Time to follow-up and cancer diagnosis, loss to follow-up, and ED recidivism were similar after index presentation assessment by ACS versus ACS and BS/SO. In a resource-limited environment, urgent breast consults can be safely managed in the acute setting by ACS with coordinated outpatient BS/SO follow-up.

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. Acute Care Surgery in the Critically Ill Neurosurgical Patient

Fundamentals of Neuroanesthesia ◽

10.1093/med/9780199755981.003.0026 ◽

2013 ◽

pp. 312-318

Author(s):

Joss J. Thomas ◽

Avinash B. Kumar

Keyword(s):

Critically Ill ◽

Acute Care ◽

Acute Care Surgery ◽

Neurosurgical Patient ◽

Care Surgery

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P074: Improving urology care in the emergency department through implementation of an Acute Care Urology model

CJEM ◽

10.1017/cem.2019.265 ◽

2019 ◽

Vol 21 (S1) ◽

pp. S90

Author(s):

A. Kirubarajan ◽

R. Buckley ◽

S. Khan ◽

R. Richard ◽

V. Stefanova ◽

...

Keyword(s):

Emergency Department ◽

Acute Care ◽

Outpatient Care ◽

Renal Colic ◽

Interdisciplinary Collaboration ◽

Wait Time ◽

Acute Care Surgery ◽

Post Intervention ◽

Care Surgery

Introduction: Renal colic is one of the most common presentations to the emergency department (ED), and often requires complex interdisciplinary collaboration between emergency physicians and urology surgeons. Previous literature has shown that adoption of interdisciplinary rapid referral clinics can improve both timeliness of care and patient outcomes. However, these Acute Care Surgery models have not yet been commonly adopted for urology care in the ED. Methods: In July 2016, we adopted the intervention of an Acute Care Urology (ACU) model through the creation of a rapid referral clinic dedicated to ED patient referrals, the addition of an ACU surgeon, and enhanced use of daytime OR blocks. We conducted a manual chart review of 579 patients presenting to the ED with a complaint of renal colic. Patient data was collected in two separate time periods to analyze trends before implementation of the ACU model (pre-intervention, September - November 2015), to examine the model's impact (post-intervention, September - November 2016). Secondary methods of evaluation included a survey of 20 ED physicians to capture subjective feedback through Likert scale data. Results: Of the evaluated 579 patients with a complaint of renal colic,194 patients were discharged from ED with an diagnosis of obstructing kidney stone and were referred to urology for outpatient care. The ED-to-clinic time was significantly lower for those in the ACU model (p <0.001). The mean time to clinic was 15.76 days (SD = 15.47, range 1-93) pre-intervention versus 4.17 days (SD = 2.33, range = 1-12) post-intervention. Furthermore, the ACU clinic allowed significantly more patients to be referred for outpatient care (p = 0.0004). There was also higher likelihood that patients would successfully obtain an appointment following referral (p = 0.0055). Decreasing trends were shown in mean ED wait time, in addition to time from assessment to procedure. Results of the qualitative survey were overwhelmingly positive. All 20 surveyed ED physicians were more confident that outpatients would be seen in a timely manner (85% strongly agree, 15% agree). Qualitative feedback included the belief that follow-up is more accessible, that ED physicians are less likely to page the on-call urologist, and that they are able to discharge patients sooner. Conclusion: The ACU model for patients with renal colic may be beneficial in reducing ED-to-clinic time, ensuring proper follow-up after ED diagnosis, and improving patient care within the ED.

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Oral Complications of ICU Patients with COVID-19: Case-Series and Review of Two Hundred Ten Cases

Journal of Clinical Medicine ◽

10.3390/jcm10040581 ◽

2021 ◽

Vol 10 (4) ◽

pp. 581 ◽

Cited By ~ 2

Author(s):

Barbora Hocková ◽

Abanoub Riad ◽

Jozef Valky ◽

Zuzana Šulajová ◽

Adam Stebel ◽

...

Keyword(s):

Critically Ill ◽

Critically Ill Patients ◽

Oral Candidiasis ◽

Case Series ◽

Immunosuppressive Drugs ◽

Acute Onset ◽

Cochrane Library ◽

Icu Patients ◽

Oral Complications ◽

Ovid Medline

Background: The critically ill patients suffering from coronavirus disease (COVID-19) and admitted to the intensive care units (ICUs) are susceptible to a wide array of complications that can be life-threatening or impose them to long-term complications. The COVID-19 oral mucocutaneous complications require multidisciplinary management and research for their pathophysiological course and epidemiological significance; therefore, the objective of this study was to evaluate the prevalence and characteristics of the critically ill COVID-19 patients with oral complications. Methods: We described the clinical and microbiological characteristics of the critically ill COVID-19 patients in our ICU department (Banska Bystrica, Slovakia). In addition, we reviewed the current body of evidence in Ovid MEDLINE®, Embase, Cochrane Library, and Google Scholar for the oral mucocutaneous complications of ICU patients with COVID-19. Results: Three out of nine critically ill patients (33.3%) in our ICU department presented with oral complications including haemorrhagic ulcers and necrotic ulcers affecting the lips and tongue. The microbiological assessment revealed the presence of opportunistic pathogens, confirming the possibility of co-infection. On reviewing the current literature, two hundred ten critically ill patients were reported to have oral complications due to their stay in the ICU setting. Perioral pressure ulcers were the most common complication, followed by oral candidiasis, herpetic and haemorrhagic ulcers, and acute onset macroglossia. The prolonged prone positioning and mechanical ventilation devices were the primary risk factors for those oral complications, in addition to the immunosuppressive drugs. Conclusions: The multidisciplinary approach is strongly advocated for monitoring and management of COVID-19 patients, thus implying that dermatology and oral healthcare specialists and nurses should be integrated within the ICU teams.

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Rescue fecal microbiota transplantation for antibiotic-associated diarrhea in critically ill patients

Critical Care ◽

10.1186/s13054-019-2604-5 ◽

2019 ◽

Vol 23 (1) ◽

Cited By ~ 10

Author(s):

Min Dai ◽

Yafei Liu ◽

Wei Chen ◽

Heena Buch ◽

Yi Shan ◽

...

Keyword(s):

Abdominal Pain ◽

Critically Ill ◽

Critically Ill Patients ◽

Potential Benefit ◽

Fecal Microbiota Transplantation ◽

Case Series ◽

Fecal Microbiota ◽

Abdominal Symptoms ◽

Antibiotic Associated Diarrhea

Abstract Background Antibiotic-associated diarrhea (AAD) is a risk factor for exacerbating the outcome of critically ill patients. Dysbiosis induced by the exposure to antibiotics reveals the potential therapeutic role of fecal microbiota transplantation (FMT) in these patients. Herein, we aimed to evaluate the safety and potential benefit of rescue FMT for AAD in critically ill patients. Methods A series of critically ill patients with AAD received rescue FMT from Chinese fmtBank, from September 2015 to February 2019. Adverse events (AEs) and rescue FMT success which focused on the improvement of abdominal symptoms and post-ICU survival rate during a minimum of 12 weeks follow-up were assessed. Results Twenty critically ill patients with AAD underwent rescue FMT, and 18 of them were included for analysis. The mean of Acute Physiology and Chronic Health Evaluation (APACHE) II scores at intensive care unit (ICU) admission was 21.7 ± 8.3 (range 11–37). Thirteen patients received FMT through nasojejunal tube, four through gastroscopy, and one through enema. Patients were treated with four (4.2 ± 2.1, range 2–9) types of antibiotics before and during the onset of AAD. 38.9% (7/18) of patients had FMT-related AEs during follow-up, including increased diarrhea frequency, abdominal pain, increased serum amylase, and fever. Eight deaths unrelated to FMT occurred during follow-up. One hundred percent (2/2) of abdominal pain, 86.7% (13/15) of diarrhea, 69.2% (9/13) of abdominal distention, and 50% (1/2) of hematochezia were improved after FMT. 44.4% (8/18) of patients recovered from abdominal symptoms without recurrence and survived for a minimum of 12 weeks after being discharged from ICU. Conclusion In this case series studying the use of FMT in critically ill patients with AAD, good clinical outcomes without infectious complications were observed. These findings could potentially encourage researchers to set up new clinical trials that will provide more insight into the potential benefit and safety of the procedure in the ICU. Trial registration ClinicalTrials.gov, Number NCT03895593. Registered 29 March 2019 (retrospectively registered).

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