NCT00527007

Brief Summary

The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 22, 2010

Status Verified

August 1, 2008

Enrollment Period

2.4 years

First QC Date

September 6, 2007

Last Update Submit

July 21, 2010

Conditions

Septic Shock

Keywords

VasopressorEpinephrineNorepinephrineCoolingFeverICU

Outcome Measures

Primary Outcomes (1)

  • Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment

    48 hours after enrolment

Secondary Outcomes (3)

  • Maximal dose of vasopressors

    within 48 hours after enrolment

  • SOFA score evolution

    on Day 3, Day 7, Day 14

  • Number of vasopressor free days in the ICU

    during the study

Study Arms (2)

A

EXPERIMENTAL
Other: External cooling

B

NO INTERVENTION

Interventions

External coolingOTHER

External cooling

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented or suspected infection
  • Body temperature \> 38.3°C
  • Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure \> 65 mmHg.
  • Invasive mechanical ventilation
  • Intravenous sedation

You may not qualify if:

  • Temperature \> 41°C
  • Age \< 18 years
  • Pregnancy
  • Continuous renal replacement therapy
  • Need for paracetamol and/or NSAI therapy during the study period
  • Burns or Lyell syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Henri Mondor

Créteil, 94000, France

Location

Related Publications (1)

  • Schortgen F, Charles-Nelson A, Bouadma L, Bizouard G, Brochard L, Katsahian S. Respective impact of lowering body temperature and heart rate on mortality in septic shock: mediation analysis of a randomized trial. Intensive Care Med. 2015 Oct;41(10):1800-8. doi: 10.1007/s00134-015-3987-7. Epub 2015 Jul 23.

    PMID: 26202042DERIVED

MeSH Terms

Conditions

Shock, SepticFever

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockBody Temperature ChangesSigns and Symptoms

Study Officials

  • Frederique SCHORTGEN, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 22, 2010

Record last verified: 2008-08

Locations

FR(1)