Protocol for fever control using external cooling in mechanically ventilated patients with septic shock : SEPSISCOOL II randomised controlled trial
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Fever treatment is commonly applied in patients with sepsis but its impact on survival remains undetermined. Patients with respiratory and haemodynamic failure are at the highest risk for not tolerating the metabolic cost of fever. However, fever can help to control infection. Treating fever with paracetamol has been shown to be less effective than cooling. In the SEPSISCOOL pilot study, active fever control by external cooling improved organ failure recovery and early survival. The main objective of this confirmatory trial is to assess whether fever control at normothermia can improve the evolution of organ failure and mortality at day 60 of febrile patients with septic shock. This study will compare two strategies within the first 48 hours of septic shock: treatment of fever with cooling or no treatment of fever.
METHODS AND ANALYSIS: SEPSISCOOL II is a pragmatic, investigator-initiated, adaptive, multicentre, open-label, randomised controlled, superiority trial in patients admitted to the intensive care unit with febrile septic shock. After stratification based on the acute respiratory distress syndrome status, patients will be randomised between two arms: (1) cooling and (2) no cooling. The primary endpoint is mortality at day 60 after randomisation. The secondary endpoints include the evolution of organ failure, early mortality and tolerance. The target sample size is 820 patients.
ETHICS AND DISSEMINATION: The study is funded by the French health ministry and was approved by the ethics committee CPP Nord Ouest II (Amiens, France). The results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER: NCT04494074.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
|---|---|
| Enthalten in: |
BMJ open - 14(2024), 1 vom: 29. Jan., Seite e069430 |
| Sprache: |
Englisch |
|---|
| Links: |
|---|
| Themen: |
Adult intensive & critical care |
|---|
| Anmerkungen: |
Date Completed 31.01.2024 Date Revised 01.02.2024 published: Electronic ClinicalTrials.gov: NCT04494074 Citation Status MEDLINE |
|---|
| doi: |
10.1136/bmjopen-2022-069430 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM367770342 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM367770342 | ||
| 003 | DE-627 | ||
| 005 | 20240201232226.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240130s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/bmjopen-2022-069430 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1277.xml |
| 035 | |a (DE-627)NLM367770342 | ||
| 035 | |a (NLM)38286691 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Guénégou-Arnoux, Armelle |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Protocol for fever control using external cooling in mechanically ventilated patients with septic shock |b SEPSISCOOL II randomised controlled trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 31.01.2024 | ||
| 500 | |a Date Revised 01.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04494074 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Fever treatment is commonly applied in patients with sepsis but its impact on survival remains undetermined. Patients with respiratory and haemodynamic failure are at the highest risk for not tolerating the metabolic cost of fever. However, fever can help to control infection. Treating fever with paracetamol has been shown to be less effective than cooling. In the SEPSISCOOL pilot study, active fever control by external cooling improved organ failure recovery and early survival. The main objective of this confirmatory trial is to assess whether fever control at normothermia can improve the evolution of organ failure and mortality at day 60 of febrile patients with septic shock. This study will compare two strategies within the first 48 hours of septic shock: treatment of fever with cooling or no treatment of fever | ||
| 520 | |a METHODS AND ANALYSIS: SEPSISCOOL II is a pragmatic, investigator-initiated, adaptive, multicentre, open-label, randomised controlled, superiority trial in patients admitted to the intensive care unit with febrile septic shock. After stratification based on the acute respiratory distress syndrome status, patients will be randomised between two arms: (1) cooling and (2) no cooling. The primary endpoint is mortality at day 60 after randomisation. The secondary endpoints include the evolution of organ failure, early mortality and tolerance. The target sample size is 820 patients | ||
| 520 | |a ETHICS AND DISSEMINATION: The study is funded by the French health ministry and was approved by the ethics committee CPP Nord Ouest II (Amiens, France). The results will be submitted for publication in peer-reviewed journals | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04494074 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a adult intensive & critical care | |
| 650 | 4 | |a clinical trial | |
| 650 | 4 | |a intensive & critical care | |
| 650 | 4 | |a statistics & research methods | |
| 700 | 1 | |a Murris, Juliette |e verfasserin |4 aut | |
| 700 | 1 | |a Bechet, Stéphane |e verfasserin |4 aut | |
| 700 | 1 | |a Jung, Camille |e verfasserin |4 aut | |
| 700 | 1 | |a Auchabie, Johann |e verfasserin |4 aut | |
| 700 | 1 | |a Dupeyrat, Julien |e verfasserin |4 aut | |
| 700 | 1 | |a Anguel, Nadia |e verfasserin |4 aut | |
| 700 | 1 | |a Asfar, Pierre |e verfasserin |4 aut | |
| 700 | 1 | |a Badie, Julio |e verfasserin |4 aut | |
| 700 | 1 | |a Carpentier, Dorothée |e verfasserin |4 aut | |
| 700 | 1 | |a Chousterman, Benjamin |e verfasserin |4 aut | |
| 700 | 1 | |a Bourenne, Jeremy |e verfasserin |4 aut | |
| 700 | 1 | |a Delbove, Agathe |e verfasserin |4 aut | |
| 700 | 1 | |a Devaquet, Jérôme |e verfasserin |4 aut | |
| 700 | 1 | |a Deye, Nicolas |e verfasserin |4 aut | |
| 700 | 1 | |a Dumas, Guillaume |e verfasserin |4 aut | |
| 700 | 1 | |a Dureau, Anne-Florence |e verfasserin |4 aut | |
| 700 | 1 | |a Lascarrou, Jean-Baptiste |e verfasserin |4 aut | |
| 700 | 1 | |a Legriel, Stephane |e verfasserin |4 aut | |
| 700 | 1 | |a Guitton, Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Jannière-Nartey, Caroline |e verfasserin |4 aut | |
| 700 | 1 | |a Quenot, Jean-Pierre |e verfasserin |4 aut | |
| 700 | 1 | |a Lacherade, Jean-Claude |e verfasserin |4 aut | |
| 700 | 1 | |a Maizel, Julien |e verfasserin |4 aut | |
| 700 | 1 | |a Mekontso Dessap, Armand |e verfasserin |4 aut | |
| 700 | 1 | |a Mourvillier, Bruno |e verfasserin |4 aut | |
| 700 | 1 | |a Petua, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Plantefeve, Gaetan |e verfasserin |4 aut | |
| 700 | 1 | |a Richard, Jean-Christophe |e verfasserin |4 aut | |
| 700 | 1 | |a Robert, Alexandre |e verfasserin |4 aut | |
| 700 | 1 | |a Saccheri, Clément |e verfasserin |4 aut | |
| 700 | 1 | |a Vong, Ly Van Phach |e verfasserin |4 aut | |
| 700 | 1 | |a Katsahian, Sandrine |e verfasserin |4 aut | |
| 700 | 1 | |a Schortgen, Frédérique |e verfasserin |4 aut | |
| 700 | 0 | |a REVA Network |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMJ open |d 2012 |g 14(2024), 1 vom: 29. Jan., Seite e069430 |w (DE-627)NLM215724372 |x 2044-6055 |7 nnns |
| 773 | 1 | 8 | |g volume:14 |g year:2024 |g number:1 |g day:29 |g month:01 |g pages:e069430 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/bmjopen-2022-069430 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 14 |j 2024 |e 1 |b 29 |c 01 |h e069430 | ||