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Strong Albumin Solutions in Patients With Septic Shock

NCT05208242 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-02-09

No results posted yet for this study

Summary

Sepsis is an increasingly recognised burden to healthcare systems worldwide. Intravenous fluid therapy is a common first-line intervention recommended by international guidelines. Hyperoncotic preparations of human albumin solution are widely available, but their efficacy has yet to be proven.

This randomised feasibility trial will test whether it is feasible to administer hyperoncotic albumin solutions as both fluid resuscitation and as a regular supplement in patients with early septic shock.

Conditions

  • Sepsis
  • Septic Shock
  • Shock, Toxic

Interventions

DRUG

hyperoncotic human albumin solution

20% human albumin solution (presented in 100ml glass bottles)

DRUG

Buffered crystalloid solutions

Buffered crystalloids solutions for all intravenous fluid therapy

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2025-04-05
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05208242 on ClinicalTrials.gov