Restricted Fluid Resuscitation in Sepsis-associated Hypotension (REFRESH) Trial

Not Applicable

Active, not recruiting

• Conditions: Sepsis; Septic Shock; Hypotension; Infection - Other infectious diseases

• Registration Number: ACTRN12616000006448
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Suspected infection
2. Systolic blood pressure <100mmHg after at least 1000mls intravenous isotonic crystalloid administered over maximum 60 minutes
3. Randomisation within 2 hours of meeting inclusion criteria

Exclusion Criteria

1. Hypotension thought due to, or contributed to by, a non-sepsis cause (e.g. arrhythmia, haemorrhage)
2. Clinical indication for further fluid replacement replacement (e.g. GI losses)
3. Transfer from another hospital
4. More than 2000mL of intravenous fluid has been given (either pre-hospital, in ED or both)
5. Likely requirement for immediate surgery
6. Age<18 years
7. Pregnancy (confirmed or suspected)
8. Patient in extremis or death is deemed imminent and inevitable
9. Patient wishes or comorbidities such that fluid loading or vasopressor support is not considered to be clinically appropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified