A comparison of two human albumin preparations used in the fluid resuscitation of critically ill adults.

Phase 1

• Conditions: Hypovolaemia associated with critical illness; MedDRA version: 19.0 Level: PT Classification code 10038749 Term: Resuscitation System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2016-001940-20-GB
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-07
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

•Admitted to the intensive care unit for less than 24 hours.
•Age 18 years or greater
•Need for fluid bolus as determined by the treating clinician
•Presence of one or more of the following physiological states: systolic BP <90 mmHg, or MAP <65 mmHg, or increasing need for vasopressor drug infusion or pulse pressure variation >12 % or stroke volume variation >12%, or Cardiac index <2.2 L/min/m2 or heart rate >100 or urinary output <20 ml/hr or either rising lactate levels or lactate levels >2 mmol/L or capillary refill time >3 seconds or central venous pressure <8 mmHg.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Confirmed or suspected pregnancy
•Patients with traumatic brain injury
•Active bleeding
•Haemoglobin level <70 g/L
•People who refuse blood products
•Patients in whom death is considered imminent (within 24 hours)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified