Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis
Language English Country Great Britain, England Media electronic
Document type Clinical Trial Protocol, Journal Article
PubMed
34078421
PubMed Central
PMC8170449
DOI
10.1186/s13063-021-05311-8
PII: 10.1186/s13063-021-05311-8
Knihovny.cz E-resources
- Keywords
- Capillary leakage, Colloids, Critically ill, Fluid management, Gelatine, Resuscitation, Sepsis,
- MeSH
- Electrolytes MeSH
- Intensive Care Units MeSH
- Clinical Trials, Phase IV as Topic MeSH
- Humans MeSH
- Plasma Volume MeSH
- Prospective Studies MeSH
- Randomized Controlled Trials as Topic MeSH
- Sepsis * diagnosis therapy MeSH
- Shock, Septic * diagnosis therapy MeSH
- Fluid Therapy MeSH
- Gelatin adverse effects MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
- Names of Substances
- Electrolytes MeSH
- Gelatin MeSH
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.
Medical Scientific Affairs B Braun Melsungen AG Carl Braun Straße 1 34212 Melsungen Germany
Université de Nantes CHU L'Hôtel Dieu 1 Place Alexis Ricordeau 44093 Nantes Cedex 1 France
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ClinicalTrials.gov
NCT02715466
