COMbining Plasmafiltration and Adsorption Clinical Trial: efficacy and safety of coupled plasma filtration adsorption for septic shock in the intensive care unit

2013 ◽  
Author(s):  
Sergio Livigni
Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gernot Marx ◽  
Kai Zacharowski ◽  
Carole Ichai ◽  
Karim Asehnoune ◽  
Vladimír Černý ◽  
...  

Abstract Background Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. Methods This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. Discussion This study aims to generate evidence regarding which regimen—a gelatine-crystalloid regimen or a pure crystalloid regimen—is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. Trial registration The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466. Registered on 17 March 2016.


2017 ◽  
Vol 27 (6) ◽  
pp. 714-729 ◽  
Author(s):  
Hassan Babamohamadi ◽  
Monir Nobahar ◽  
Jalaladin Razi ◽  
Raheb Ghorbani

The present study was conducted to determine the effectiveness of vitamin A eye ointment (VAEO) and moist chamber (MC) in preventing ocular surface disorders (OSD) in intensive care unit (ICU) patients. A total of 38 eligible patients were selected for participation in the present clinical trial. All the patients were randomly administered VAEO in one eye every 6 hr for 5 days and had a polyethylene cover (PC) placed on their other eye to create an MC that was replaced every 12 hr as well. The results of Schirmer’s test also increased by 2.06 mm in the VAEO group ( p < .001), while they showed a slight reduction by 0.15 mm in the MC group ( p = .669). VAEO was more effective in preventing OSD in ICU patients than MC and is, therefore, recommended to be used as a method of preventing OSD.


2017 ◽  
Vol 56 (5) ◽  
pp. 304 ◽  
Author(s):  
Desy Rusmawatiningtyas ◽  
Nurnaningsih Nurnaningsih

Background Septic shock remains a major cause of morbidity and mortality in children admitted to the intensive care unit. Recent investigations from developed countries have reported mortality rates of 20-30%. Few studies have reported mortality rates from pediatric septic shock in intensive care settings in developing countries with limited resources.  Objective  To determine the current mortality rates for pediatric patients with septic shock in a developing country.Methods A retrospective study was conducted in the Pediatric Intensive Care Unit (PICU) at DR. Sardjito General Hospital. Medical records and charts were reviewed and recorded for diagnoses of septic shock, from November 1st, 2011 to June 30th, 2014. Results  A database of all PICU admissions was assembled, and cases with diagnoses of septic shock were reviewed. The final data consisted of 136 patients diagnosed with septic shock. Septic shock was defined as a clinical suspicion of sepsis, manifested by hyperthermia or hypothermia, and accompanied by hypoperfusion  The overall mortality rate for the study cohort was 88.2%.  The median age of patients was 16 months, with 52.2% males. Median initial PRISM III and PELOD scores were 10 and 22, respectively. The median length of PICU stay was 4 days. A total of 48.5% of the subjects were in need of crystalloid and colloid fluid at a median amount of 40 mL/kg. The median time required to complete the initial resuscitation was 60 minutes. Mechanical ventilator support in the first 24 hours was required in 79.4% of the cases. Fluid overload of > 10% (FO>10%) was found in 58.8% of the subjects.Conclusion The mortality rate in pediatric septic shock in our hospital is very high. There is a higher incidence of fluid overload in the non-survival group .


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hyung-Jun Kim ◽  
Kyeongman Jeon ◽  
Byung Ju Kang ◽  
Jong-Joon Ahn ◽  
Sang-Bum Hong ◽  
...  

Abstract Background Rapid response systems (RRSs) improve patients’ safety, but the role of dedicated doctors within these systems remains controversial. We aimed to evaluate patient survival rates and differences in types of interventions performed depending on the presence of dedicated doctors in the RRS. Methods Patients managed by the RRSs of 9 centers in South Korea from January 1, 2016, through December 31, 2017, were included retrospectively. We used propensity score-matched analysis to balance patients according to the presence of dedicated doctors in the RRS. The primary outcome was in-hospital survival. The secondary outcomes were the incidence of interventions performed. A sensitivity analysis was performed with the subgroup of patients diagnosed with sepsis or septic shock. Results After propensity score matching, 2981 patients were included per group according to the presence of dedicated doctors in the RRS. The presence of the dedicated doctors was not associated with patients’ overall likelihood of survival (hazard ratio for death 1.05, 95% confidence interval [CI] 0.93‒1.20). Interventions, such as arterial line insertion (odds ratio [OR] 25.33, 95% CI 15.12‒42.44) and kidney replacement therapy (OR 10.77, 95% CI 6.10‒19.01), were more commonly performed for patients detected using RRS with dedicated doctors. The presence of dedicated doctors in the RRS was associated with better survival of patients with sepsis or septic shock (hazard ratio for death 0.62, 95% CI 0.39‒0.98) and lower intensive care unit admission rates (OR 0.53, 95% CI 0.37‒0.75). Conclusions The presence of dedicated doctors within the RRS was not associated with better survival in the overall population but with better survival and lower intensive care unit admission rates for patients with sepsis or septic shock.


2020 ◽  
Vol 48 (5) ◽  
pp. 399-405
Author(s):  
Cyril Pernod ◽  
◽  
Antoine Lamblin ◽  
Andrei Cividjian ◽  
Patrick Gerome ◽  
...  

1971 ◽  
Vol 2 (4) ◽  
pp. 327-332
Author(s):  
Roy G. Fitzgerald

This is an autobiographical account of an episode of life-threatening endotoxin shock experienced in the intensive care unit of a university-affiliated V.A. hospital. It was written within a day of the event by a psychiatrist interested in sharing with other physicians and nurses his harrowing time as a patient. He has added some afterthoughts as his perspective has broadened. The account presents the moment-to-moment events as he perceived them as well as his thoughts, feelings and fantasies. The ambiguities of being a psychiatrist-patient with its passivity-control, intellectual defenses, denial and fears of death are prominent in his thoughts.


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