Strong Albumin Solutions in Patients With Septic Shock

NCT05208242 | Completed Phase 2 FDA Drug

• 2 other identifiers: B01459287590
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

sepsis; septic shock; fluid therapy; hyperoncotic albumin

Outcome Measures

Primary Outcomes (1)

• Participant recruitment rate

  Evidence to confirm feasibility of the study protocol without any further modification for a future efficacy trial. This will be objectively determined by a recruitment rate of \>2 participants per month, resulting in study recruitment being completed within 24 months of opening the trial. A pre-specified threshold of \>80% of the anticipated recruitment rate would support the feasibility of a future efficacy trial.

  24 months after opening the trial

Secondary Outcomes (5)

• Vasopressor use

  hourly values for up to 7-days

• Survival

  90-days after enrolment

• Healthcare costs

  90-days after enrolment

• Quality of Life of study participants

  90-days after enrolment

• Cumulative fluid balance (in millilitres)

  daily values for up to 7 days

Study Arms (2)

Hyperoncotic albumin

EXPERIMENTAL

Hyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days.

Drug: hyperoncotic human albumin solution

Buffered crystalloids

ACTIVE COMPARATOR

Buffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation.

Drug: Buffered crystalloid solutions

Interventions

hyperoncotic human albumin solution DRUG

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

Hyperoncotic albumin

Buffered crystalloid solutions DRUG

Buffered crystalloids solutions for all intravenous fluid therapy

Also known as: Hartmann's solution, Compound Sodium Lactate

Buffered crystalloids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or documented infection
• Organ dysfunction defined as SOFA score ≥2
• Need for vasopressor infusion for ≥2 hours
• Serum lactate ≥2 mmol/L
• Eligible for critical care admission without any restrictions

You may not qualify if:

• \<18 years of age
• Pregnancy
• Patients with a known allergy to albumin
• Jehova's witnesses or other patients expressing a known objection to the use of blood products
• Previous receipt of human albumin solution for the episode of sepsis in question
• Previous enrolment in this study

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (2)

Manchester Royal Infirmary

Manchester, Lancashire, M13 9WL, United Kingdom

Location

Wythenshawe Hospital

Manchester, Lancashire, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A multi-centre, randomised, open-label, feasibility study.

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 26, 2022
• Study Start: November 10, 2023
• Primary Completion: April 5, 2025
• Study Completion: January 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)