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Colloid

Albumin Human for Burns (ABRUPT2 Trial)

N/A

Recruiting

Led By David G Greenhalgh, MD

Research Sponsored by American Burn Association

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

There is a plan for formal fluid resuscitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24, 48, 72, and 96 hours post burn injury

Awards & highlights

ABRUPT2 Trial Summary

This trial will compare two methods of fluid resuscitation for people with burns covering at least 25% of their body.

Who is the study for?

Adults with severe burns covering at least 25% of their body, admitted to a burn center within 12 hours of injury and needing fluid resuscitation can join. Excluded are those with major trauma, certain pre-injury conditions like kidney or liver disease, heart dysfunction, pregnancy, or specific treatments received before the trial.Check my eligibility

What is being tested?

The study is testing two ways to help adults recover from severe burns by giving fluids. One group gets lactated Ringer's solution plus albumin (a protein), while the other gets just lactated Ringer's. The goal is to see which method works better for resuscitation.See study design

What are the potential side effects?

Albumin may cause allergic reactions, fluid overload leading to swelling or heart problems, and electrolyte imbalances. Lactated Ringer’s might lead to similar issues but without the risks associated with proteins.

ABRUPT2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a procedure to receive fluids for my condition.

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Over 25% of my body is burned.

ABRUPT2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24, 48, 72, and 96 hours post burn injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24, 48, 72, and 96 hours post burn injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48, 72, and 96 hours post burn injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Kidney Failure, Acute

Duration of intubation/mechanical ventilation

Number of crossovers

+10 more

ABRUPT2 Trial Design

2Treatment groups

Active Control

Group I: CrystalloidActive Control1 Intervention

Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight.

Group II: ColloidActive Control1 Intervention

Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Burn AssociationLead Sponsor

10 Previous Clinical Trials

1,754 Total Patients Enrolled

8 Trials studying Burns

1,646 Patients Enrolled for Burns

United States Department of DefenseFED

865 Previous Clinical Trials

327,299 Total Patients Enrolled

17 Trials studying Burns

1,123 Patients Enrolled for Burns

David G Greenhalgh, MDPrincipal InvestigatorUC Davis Health

Media Library

Albumin Human (Colloid) Clinical Trial Eligibility Overview. Trial Name: NCT04356859 — N/A

Burns Research Study Groups: Crystalloid, Colloid

Burns Clinical Trial 2023: Albumin Human Highlights & Side Effects. Trial Name: NCT04356859 — N/A

Albumin Human (Colloid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04356859 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are currently hosting this experiment?

"The current iteration of this medical trial is located at 26 different sites, 3 of which are in Pittsburgh, Edmonton and Madison. It may be beneficial to select a clinic nearby in order to limit travel time should you choose to enroll."

Answered by AI

What are the primary applications of Colloid as a form of medical treatment?

"Colloid is a frequently prescribed treatment for peritonitis. It also shows efficacy in helping patients with liver failure, hypovolemia prophylaxis, and adult respiratory distress syndrome."

Answered by AI

How many participants have enrolled in this clinical research?

"This medical study necessitates 400 applicants who qualify for the required eligibility criteria. West Penn Hospital in Pittsburgh, Pennsylvania and University of Alberta in Edmonton, Alberta are two potential sites to participate from."

Answered by AI

Have there been any previous investigations dealing with Colloid?

"The first investigation into the effects of colloid was conducted in 2007 at Herbert Irving Pavillion 11th Floor. Since then, 174 clinical trials have concluded and 133 are currently ongoing - many based out of Pittsburgh, Pennsylvania."

Answered by AI

Is this trial a pioneering investigation into the subject matter?

"At the time of writing, there are 133 ongoing trials involving Colloid across 918 cities in 32 countries. The first such trial began back in 2007 and was sponsored by Celgene Corporation with 47 patients participating. Since then, 174 studies have been conclusively finished."

Answered by AI

Are there any vacant positions in this medical experiment?

"At present, clinicaltrials.gov states that this experimental trial is recruiting participants. It was initially advertised on April 22nd 2021 and underwent its last update on August 9th 2022."

Answered by AI

Recent research and studies

Annals of the New York Academy of SciencesJournal

Physiological Response to Crystalloid Resuscitation of Severe Burns

Baxter, Charles R., and Tom Shires. 1968. “Physiological Response to Crystalloid Resuscitation of Severe Burns”. Annals of the New York Academy of Sciences. Wiley. doi:10.1111/j.1749-6632.1968.tb14738.x.

BurnsJournal

Clinical Study of a Formula for Delayed Rapid Fluid Resuscitation for Patients with Burn Shock

Huang, Yuesheng, Baigang Yan, and Zongcheng Yang. 2005. “Clinical Study of a Formula for Delayed Rapid Fluid Resuscitation for Patients with Burn Shock”. Burns. Elsevier BV. doi:10.1016/j.burns.2005.02.002.

Current Problems in SurgeryJournal

The Burn Patient: II. Later Care and Complications of Thermal Injury

Pruitt, Basil A., Jr.. 1979. “The Burn Patient: II. Later Care and Complications of Thermal Injury”. Current Problems in Surgery. Elsevier BV. doi:10.1016/s0011-3840(79)80009-x.

BurnsJournal