Can Mild Induced Hypothermia reduce mortality in septic shock patients at the Intensive Care Unit? A randomized, single-blinded, multicenter study. The cooling and surviving septic shock study

Completed

• Conditions: blood poisening; Sepsis; 10005908; 10004018

• Registration Number: NL-OMON44609
• Lead Sponsor: CHIP HIV copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

- Aged 50 years or older.
- Severe sepsis/septic shock
- Admitted to the participating intensive care units (ICU)
- (Indication for) mechanical ventilation
- Possibility of inclusion within 6 hours after septic shock/severe sepsis is diagnosed in the ICU.
- Expected stay in the ICU of more than 24 hours

Exclusion Criteria

- Pregnant or breast feeding
- Bleeding disorder and/or uncontrollable bleeding and /or surgery within the last 24 hours or expected surgery in the coming 12 hours
- Persons who are detained under the Act on the use of coercion in psychiatry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>All cause mortality at 30 days</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Duration of cardiac/septic shock<br /><br>2. Respiratory failure<br /><br>3. Renal failure<br /><br>4. Cerebral dysfunction<br /><br>5. Liver failure<br /><br>6. Coagulation disorders<br /><br>7. Infection parameters<br /><br>8. Days without organ failure up to day 30 </p><br>