scholarly journals Clinical Characteristics and Outcomes of Critically Ill Mechanically Ventilated Patients Receiving Adjunctive Ketamine for Sedation: an Investigator-Driven, Open-Label, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Marwa Amer ◽  
Mohammed Bawazeer ◽  
Khalid Maghrabi ◽  
Kamel Alshaikh ◽  
Mohammad Shaban ◽  
...  
Keyword(s):  
Clinical Characteristics ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Adherence Rate ◽  
Consent Rate ◽  
Open Label ◽  
Icu Patients ◽  
Mechanically Ventilated

AbstractBackgroundKetamine has been shown to decrease sedative requirements in intensive care unit (ICU). Randomized trials are lacking on patient-centered outcomes. We aimed to compare the clinical characteristics and outcomes of mechanically ventilated adult ICU patients receiving ketamine as an adjunct analgosedative with those receiving standard of care (SOC) alone. We also described the feasibility during COVID-19 pandemic.MethodsIn this randomized, open-label trial either ketamine or SOC, in a 1:1 ratio, was administered to patients who were intubated within 24 hours (medical, surgical, or transplant/oncology ICUs), expected to require mechanical ventilation (MV) for the next calendar day, and had the institutional pain and sedation protocol initiated. Ketamine infusion was 2 μg/kg/min on day 1 and 1 μg/kg/min on day 2. The primary outcome was the 28-day MV duration and ventilator-free days as co-primary outcome. Cox-proportional regression analysis was used to assess factors associated with probability for weaning off MV.ResultsA total of 83 patients (43 in SOC and 40 in ketamine) were included. Demographics were balanced between the groups. The median duration of MV was not significantly different between the groups [median (interquartile range): 7 (3-9.25) for ketamine and 5 (2-8) for SOC, p= 0.15]. The median ventilation-free days was 19 days (IQR 0-24.75) in the ketamine and 19 days (IQR 0-24) in the SOC (p=0.70). Surgical and transplant/oncology ICU patients had a higher probability of weaning off MV than those in medical ICU [hazard ratio (95% confidence interval): 2.09 (1.06–4.14) for surgical ICU, 2.11 (1.02–4.35) for transplant/oncology ICU]. More patient was at goal RASS in ketamine compared to SOC. The sedatives and vasopressors cumulative doses were similar between the two arms at 48 hours. We found no difference in 28-day mortality rate, ICU and hospital length of stay, and hemodynamic changes. The consent rate was adequate and the protocol adherence rate was 97.5%.ConclusionsKetamine as an adjunct agent for sedation did not decrease the duration of MV and appeared to be safe, feasible, and effective in subgroups of ICU patients. No effect was noted in sedative and pressors requirements, or on hemodynamics.Trial registrationClinicalTrials.gov: NCT04075006 and current-controlled trials: ISRCTN14730035

Effect of Early versus Late Tracheostomy Placement on Survival in Patients Receiving Mechanical Ventilation

2018 ◽  
pp. 157-162
Author(s):  
J. Michael Guthrie ◽  
Vadim Gudzenko
Keyword(s):  
Mechanical Ventilation ◽  
Prolonged Mechanical Ventilation ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Icu Patients ◽  
Early Tracheostomy ◽  
Mechanically Ventilated ◽  
Study Intervention

The TracMan randomized controlled trial examined mortality among patients randomized to receive early (first 4 days) versus late (after 10 days) tracheostomy. This chapter describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. It briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. The study found that early tracheostomy did not improve mortality in mechanically ventilated ICU patients. Early tracheostomy did not improve important patient outcomes such as ICU or hospital length of stay. The study also demonstrated that clinicians’ ability to predict which ICU patients will require prolonged mechanical ventilation is severely limited.

Daily Interruption of Sedation with Physical and Occupational Therapy in Mechanically Ventilated Patients

2018 ◽  
pp. 309-316
Author(s):  
Michael Wolfe ◽  
Daniel Saddawi-Konefka
Keyword(s):  
Occupational Therapy ◽  
Functional Status ◽  
Intervention Group ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Control Group ◽  
Icu Patients ◽  
Mechanically Ventilated ◽  
Mechanically Ventilated Patients ◽  
Ventilated Patients

Schweickert et al. studied effects of early physical and occupational therapy in mechanically ventilated patients. 109 mechanically ventilated medical ICU patients (with independent functional status prior to hospitalization) were randomized to receive physical and occupational therapy initiated at time of enrollment (intervention group) vs. physical and occupational therapy ordered at the discretion of the primary team (control group), with both groups receiving daily interruptions of sedation. The primary outcome, independent functional status at time of discharge, was met in 59% of the intervention group vs. 35% of the control group (p = 0.02). Lower rates of ICU and hospital delirium were observed in the intervention group. Hospital length of stay and mortality were unaffected. This study demonstrated that physical and occupational therapy can be safely accomplished in critically ill, mechanically ventilated medical ICU patients, and that early implementation of therapy may improve return to independent functional status at hospital discharge.

scholarly journals Early Anti-SARS-CoV-2 Convalescent Plasma in Patients Admitted for COVID-19: A Randomized Phase II Clinical Trial

2020 ◽  
Author(s):  
María Elvira Balcells ◽  
Luis Rojas ◽  
Nicole Le Corre ◽  
Constanza Martínez-Valdebenito ◽  
María Elena Ceballos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Clearance Rate ◽  
Primary Outcome ◽  
Group Versus ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Open Label ◽  
Serious Adverse Events ◽  
Academic Center

Background: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. Methods: Open-label, single-center, randomized clinical trial performed in an academic center in Santiago, Chile from May 10, 2020, to July 18, 2020, with final follow-up August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptoms onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted in immediate CP (early plasma group) versus no CP unless developing pre-specified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days or death. Key secondary outcomes included: time to respiratory failure, days of mechanical ventilation, hospital length-of-stay, mortality at 30 days, and SARS-CoV-2 RT-PCR clearance rate. Results: Of 58 randomized patients (mean age, 65.8 years, 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We found no benefit in the primary outcome (32.1% vs 33.3%, OR 0.95, 95% CI 0.32-2.84, p>0.99) in the early versus deferred CP group. In-hospital mortality rate was 17.9% vs 6.7% (OR 3.04, 95% CI 0.54-17.2, p=0.25), mechanical ventilation 17.9% vs 6.7% (OR 3.04, 95% CI 0.54-17.2, p=0.25), and prolonged hospitalization 21.4% vs 30% (OR 0.64, 95%CI, 0.19-2.1, p=0.55) in early versus deferred CP group, respectively. Viral clearance rate on day 3 (26% vs 8%, p=0.20) and day 7 (38% vs 19%, p=0.37) did not differ between groups. Two patients experienced serious adverse events within 6 or less hours after plasma transfusion. Conclusion: Immediate addition of CP therapy in early stages of COVID-19 -compared to its use only in case of patient deterioration- did not confer benefits in mortality, length of hospitalization or mechanical ventilation requirement.

Nurse-Performed Ultrasound-Guided Technique for Difficult Peripheral Intravenous Access in Critically Ill Patients: A Randomized Controlled Trial

2020 ◽  
Vol 25 (2) ◽  
pp. 34-39 ◽  
Author(s):  
Takuya Nishizawa ◽  
Takashi Matsumoto ◽  
Takafumi Todaka ◽  
Mikio Sasano ◽  
Hironobu Kitagawa ◽  
...  
Keyword(s):  
Success Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Success Rates ◽  
Open Label ◽  
Icu Patients ◽  
Peripheral Intravenous Access ◽  
To Receive ◽  
Patient Enrollment

Highlights Abstract Purpose: The aim of this study was to compare nurse-performed ultrasound (US)-guided technique with standard of care (SOC) technique for difficult peripheral intravenous (PIV) access among patients admitted to the intensive care unit (ICU). Materials and Methods: This was a randomized, prospective, open-label single-site study. ICU nurses completed a standardized training program for US-guided PIV access placement before patient enrollment. ICU patients with difficult PIV access were randomized to either nurse-performed US-guided technique or SOC technique. Primary outcome was success rate on the first attempt. Secondary outcomes were success rate after 2 attempts and frequency of complications after successful placement. Results: A total of 60 patients were enrolled; 30 were randomized to receive US-guided technique, and 30 to SOC technique. Success rate on the first attempt was significantly higher with US-guided technique compared with SOC technique (70% vs 40%; P < 0.05). Success rates after 2 attempts were 73.3% for US-guided technique and 46.6% for SOC technique (P = 0.065). Extravasation after successful placement occurred in 13.6% of patients with US-guided technique, and 28.6% of patients with SOC technique (P = 0.394). Conclusions: Among ICU patients with difficult PIV access, US-guided PIV access placement by nurses who underwent standardized training was more successful than placement with SOC technique.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals 562. Tocilizumab for the Treatment of Severe COVID-19: A Retrospective, Multi-Center, Case-Matched Series

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S346-S346
Author(s):  
Sarah Norman ◽  
Sara Jones ◽  
David Reeves ◽  
Christian Cheatham
Keyword(s):  
Mechanical Ventilation ◽  
Length Of Stay ◽  
Hospital Mortality ◽  
Primary Outcome ◽  
Fungal Infections ◽  
Hospital Length ◽  
Hospitalized Patients ◽  
Hospital Length Of Stay ◽  
Matched Design ◽  
Median Hospital

Abstract Background At the time of this writing, there is no FDA approved medication for the treatment of COVID-19. One medication currently under investigation for COVID-19 treatment is tocilizumab, an interleukin-6 (IL-6) inhibitor. It has been shown there are increased levels of cytokines including IL-6 in severe COVID-19 hospitalized patients attributed to cytokine release syndrome (CRS). Therefore, inhibition of IL-6 receptors may lead to a reduction in cytokines and prevent progression of CRS. The purpose of this retrospective study is to utilize a case-matched design to investigate clinical outcomes associated with the use of tocilizumab in severe COVID-19 hospitalized patients. Methods This was a retrospective, multi-center, case-matched series matched 1:1 on age, BMI, and days since symptom onset. Inclusion criteria included ≥ 18 years of age, laboratory confirmed positive SARS-CoV-2 result, admitted to a community hospital from March 1st – May 8th, 2020, and received tocilizumab while admitted. The primary outcome was in-hospital mortality. Secondary outcomes included hospital length of stay, total mechanical ventilation days, mechanical ventilation mortality, and incidence of secondary bacterial or fungal infections. Results The following results are presented as tocilizumab vs control respectively. The primary outcome of in-hospital mortality for tocilizumab (n=26) vs control (n=26) was 10 (38%) vs 11 (42%) patients, p=0.777. The median hospital length of stay for tocilizumab vs control was 14 vs 11 days, p=0.275. The median days of mechanical ventilation for tocilizumab (n=21) vs control (n=15) was 8 vs 7 days, p=0.139, and the mechanical ventilation mortality was 10 (48%) vs 9 (60%) patients, p=0.463. In the tocilizumab group, for those expired (n=10) vs alive (n=16), 10 (100%) vs 7 (50%) patients respectively had a peak ferritin &gt; 600 ng/mL, and 6 (60%) vs 8 (50%) patients had a peak D-dimer &gt; 2,000 ng/mL. The incidence of secondary bacterial or fungal infections within 7 days of tocilizumab administration occurred in 5 (19%) patients. Conclusion These findings suggest that tocilizumab may be a beneficial treatment modality for severe COVID-19 patients. Larger, prospective, placebo-controlled trials are needed to further validate results. Disclosures Christian Cheatham, PharmD, BCIDP, Antimicrobial Resistance Solutions (Shareholder)

scholarly journals Cardiac Injuries at Estonian Major Trauma Facilities: A 23-year Perspective

2018 ◽  
Vol 108 (2) ◽  
pp. 159-163 ◽  
Author(s):  
M. Einberg ◽  
S. Saar ◽  
A. Seljanko ◽  
A. Lomp ◽  
U. Lepner ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Primary Outcome ◽  
Major Trauma ◽  
Alcohol Intoxication ◽  
Cardiac Injury ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Cardiac Trauma ◽  
Icd 10 ◽  
Overall Mortality

Background and Aims: Cardiac injuries are highly lethal lesions following trauma and most of the patients decease in pre-hospital settings. However, studies on cardiac trauma in Estonia are scarce. Thus, we set out to study cardiac injuries admitted to Estonian major trauma facilities during 23 years of Estonian independence. Materials and Methods: After the ethics review board approval, all consecutive patients with cardiac injuries per ICD-9 (861.0 and 861.1) and ICD-10 codes (S.26) admitted to the major trauma facilities between 1 January 1993 and 31 July 2016 were retrospectively reviewed. Cardiac contusions were excluded. Data collected included demographics, injury profile, and in-hospital outcomes. Primary outcome was mortality. Secondary outcomes were cardiac injury profile and hospital length of stay. Results: During the study period, 37 patients were included. Mean age was 33.1 ± 12.0 years and 92% were male. Penetrating and blunt trauma accounted for 89% and 11% of the cases, respectively. Thoracotomy and sternotomy rates for cardiac repair were 80% and 20%, respectively. Most frequently injured cardiac chamber was left ventricle at 49% followed by right ventricle, right atrium, and left atrium at 34%, 17%, and 3% of the patients, respectively. Multi-chamber injury was observed at 5% of the cases. Overall hospital length of stay was 13.5 ± 16.7 days. Overall mortality was 22% (n = 8) with uniformly fatal outcomes following left atrial and multi-chamber injuries. Conclusion: Overall, 37 patients with cardiac injuries were hospitalized to national major trauma facilities during the 23-year study period. The overall in-hospital mortality was 22% comparing favorably with previous reports. Risk factors for mortality were initial Glasgow Coma Scale < 9, pre-hospital cardiopulmonary resuscitation, and alcohol intoxication.

scholarly journals Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC): a pilot randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029394 ◽  
Author(s):  
Kimberley Lewis ◽  
Sarah Culgin ◽  
Roman Jaeschke ◽  
Dan Perri ◽  
Corry Marchildon ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Laryngeal Oedema ◽  
Leak Test ◽  
Icu Patients ◽  
Pilot Randomised Controlled Trial ◽  
Mechanically Ventilated ◽  
Cuff Leak ◽  
Randomised Controlled

IntroductionEndotracheal intubation and invasive mechanical ventilation are lifesaving interventions that are commonly performed in the intensive care unit (ICU). Laryngeal oedema is a known complication of intubation that may cause airway obstruction in a patient on extubation. To date, the only test available to predict this complication is the cuff leak test (CLT); however, its diagnostic accuracy and utility remains uncertain. Herein, we report the protocol for the CuffLeak and AirwayObstruction in MechanicallyVentilated ICU Patients (COMIC) pilottrial.Methods and analysisThis will be a multicentred, pragmatic, pilot randomised controlled trial (RCT). We will enrol 100 mechanically ventilated patients in the ICU who are deemed ready for extubation. We will exclude patients at a high risk of laryngeal oedema. All enrolled patients will have a CLT done before extubation. In the intervention arm, the results of the CLT will be communicated to the bedside physician, and decision to extubate will be left to the treating team. In the control arm, respiratory therapist will not communicate the results of the CLT to the treating physician, and the patient will be extubated regardless of the CLT result. Randomisation will be done in a 1:1 allocation ratio, stratified by size of the endotracheal tube and duration of invasive mechanical ventilation.Although we will examine all clinical outcomes relevant for the future COMIC RCT, the primary outcomes of the COMIC pilottrial will be feasibility outcomes including: consent rate, recruitment rate and protocol adherence. Clinical outcomes include postextubation stridor, reintubation, emergency surgical airway, ICU mortality, in hospital mortality, duration of mechanical ventilation and ICU length of stay in days.Ethics and disseminationThe Hamilton Integrated Research Ethics Board, Imam Abdulrahman Bin Faisal University Institutional Review Board and Bioethical Commission of the Jagiellonian University approved this study. The trial results will be disseminated via publication in peer-reviewed journals.Trial registration numberNCT03372707.

Extended infusion compared to standard infusion cefepime as empiric treatment of febrile neutropenia

2017 ◽  
Vol 24 (3) ◽  
pp. 170-175 ◽  
Author(s):  
Rebekah H Wrenn ◽  
David Cluck ◽  
LeAnne Kennedy ◽  
Christopher Ohl ◽  
John C Williamson
Keyword(s):  
Febrile Neutropenia ◽  
Creatinine Clearance ◽  
Primary Outcome ◽  
Clinical Success ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Secondary Outcome ◽  
Cell Transplant ◽  
To Receive ◽  
Extended Infusion

Background Extended infusion (EI) dosing provides a longer time above the minimum inhibitory concentration, which is important for the clinical success of β-lactam antibiotics, especially for patients with impaired immunity. The aim of this study was to determine the feasibility and clinical impact of administering cefepime by EI as treatment of febrile neutropenia. Methods This was a prospective, randomized, comparative pilot study. All patients received cefepime 2 g IV every 8 h, with the first dose administered using a 30-min infusion. After the first dose, patients were randomized to receive cefepime over 30 min as a standard infusion (SI) or 3 h (EI). Patients were >18 years old with febrile neutropenia (neutrophil count <500 cells/mm3 and temperature >38.0ºC) and received chemotherapy or stem cell transplant as treatment for malignancy. Patients were excluded for the following: allergy to a cephalosporin, creatinine clearance (CrCl) < 50 mL/min, receipt of concurrent Gram-negative antimicrobial, sepsis, or solid tumor malignancy. The primary outcome was defervescence by 72 h. Secondary outcomes included time to defervescence, clinical success, in-hospital mortality, hospital length of stay, and need for additional antimicrobials. Main results Sixty-three patients were enrolled: 33 in the SI arm and 30 in the EI arm. The groups were similar with regard to age, gender, weight, estimated creatinine clearance, and duration of neutropenia. None of the patients in the EI arm withdrew due to practical complications of receiving EI cefepime. Twenty-three patients in the SI arm and 20 patients in the EI arm defervesced by 72 h ( p = 0.99). There were no differences in secondary outcome measures; however, patients in the EI arm appeared to have defervesced more rapidly (median 19 vs. 41 h, p = 0.305). Conclusion Administration of cefepime by EI for the treatment of febrile neutropenia is feasible. Larger clinical trials are necessary to determine if EI cefepime imparts a clinical benefit in the treatment of febrile neutropenia.

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