scholarly journals Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study

Critical Care ◽  
10.1186/11358 ◽  
2012 ◽  
Vol 16 (3) ◽  
Author(s):  
Bertrand Guidet ◽  
Olivier Martinet ◽  
Thierry Boulain ◽  
Francois Philippart ◽  
Jean François Poussel ◽  
...  
Keyword(s):  
Severe Sepsis ◽  
Fluid Replacement ◽  
Efficacy And Safety

scholarly journals Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study

Critical Care ◽  
2012 ◽  
Vol 16 (3) ◽  
pp. R94 ◽  
Author(s):  
Bertrand Guidet ◽  
Olivier Martinet ◽  
Thierry Boulain ◽  
Francois Philippart ◽  
Jean Poussel ◽  
...  
Keyword(s):  
Severe Sepsis ◽  
Fluid Replacement ◽  
Efficacy And Safety

scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gernot Marx ◽  
Kai Zacharowski ◽  
Carole Ichai ◽  
Karim Asehnoune ◽  
Vladimír Černý ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Severe Sepsis ◽  
Plasma Volume ◽  
Volume Replacement ◽  
Efficacy And Safety ◽  
Volume Responsiveness ◽  
Double Blind ◽  
Link Type ◽  
Icu Discharge

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.

Efficacy and Safety of Recombinant Human Activated Protein C for Severe Sepsis

2018 ◽  
pp. 61-67
Author(s):  
Anna M. Ward ◽  
Richard M. Pino
Keyword(s):  
Severe Sepsis ◽  
Study Design ◽  
Protein C ◽  
Clinical Case ◽  
Activated Protein C ◽  
Efficacy And Safety ◽  
Prowess Trial ◽  
Study Intervention ◽  
Prowess Study

This chapter provides a summary of the landmark study known as the PROWESS Study. Does treatment with DAA reduce the rate of death from any cause among patients with severe sepsis? Starting with that question, it 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. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. The PROWESS trial demonstrated a mortality benefit for DAA among patients with severe sepsis. However, the subsequent ADDRESS, RESOLVE, and PROWESS-SHOCK trials did not demonstrate a benefit of the medication, thus calling the results of PROWESS into question.

Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab′)2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels*

2004 ◽  
Vol 32 (11) ◽  
pp. 2173-2182 ◽  
Author(s):  
Edward A. Panacek ◽  
John C. Marshall ◽  
Timothy E. Albertson ◽  
David H. Johnson ◽  
Steven Johnson ◽  
...  
Keyword(s):  
Severe Sepsis ◽  
Tumor Necrosis Factor ◽  
Interleukin 6 ◽  
Tumor Necrosis ◽  
Efficacy And Safety ◽  
Necrosis Factor

International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: Analysis of efficacy and safety data in a large surgical cohort

Surgery ◽  
2006 ◽  
Vol 140 (5) ◽  
pp. 726-739 ◽  
Author(s):  
Didier Payen ◽  
Armin Sablotzki ◽  
Philip S. Barie ◽  
Graham Ramsay ◽  
Stephen Lowry ◽  
...  
Keyword(s):  
Severe Sepsis ◽  
Drotrecogin Alfa ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Drotrecogin Alfa Activated
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