Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

September 5, 2013 updated by: Honghui Zhang, Tang-Du Hospital

Colloid Improves Organ Function by Reducing the Elevation of Intra-abdominal Pressure in Resuscitation of Critical Burn Patients

The present study was to evaluate the effectiveness of colloid compared with crystalloids for fluid resuscitation in critical burn patients with total burn surface area ≥50%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Extensive burn patients are some of the most challenging critically ill patients who may have multiple-system organ failure with life-threatening complications.Over time, several resuscitation formulae have been proposed to guide burn resuscitation and the best known ones are Parkland and Evans formulae. The main controversy between the two formulae also focuses on whether to infuse the colloid in the first 24 h.Controversy continues and the conflicting results left many clinicians unsure about the effect of colloids on fluid resuscitation in extensive burn patients who suffer higher risk of hypovolaemia, abdominal compartment syndrome (ACS), multiple organs dysfunction and mortality. To address this uncertainty, we conducted a prospective, randomized, controlled clinical trial to compare fluid resuscitation in extensive burns guided by Parkland formulae with TMMU formulae as a modified Evans formula routinely used in China.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Department of Burn and Plastic Surgery,Tangdu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study was performed in the Department of Burn Intensive Care of the Tangdu Hospital, an academic hospital of the Fourth Military Medical University of Xi'an. populaitons were extensive burns who admitted to our hospital within 4 h since burn injury.

Description

Inclusion Criteria:

  • burn patients with total burn surface area ≥50% and full thickness burn surface area ≥30%.

Exclusion Criteria:

  • age <18 yrs, time between burn injury and fluid infusion > 4 h, time arriving at our burn centre > 6 h, pre-existing medical illnesses compromising the cardiopulmonary reserve or those need for compassionate care only.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkland group
Extensive burn patients are resuscitated with Parkland formula.In the first 24h of resuscitation,crystalloids were infused as the main fluid.
TMMU group
Extensive burn patients are resuscitated with Third Military Medical University (TMMU) formula as a modified EVANS formula routinely used in China. In the first 24h of resuscitation, crystalloids and colloids were infused together.
Drug: colloids
TMMU group allows for administration of colloids early,while Parkland group infuse colloids 24 h after burn injury.
Other Names:
  • frozen fresh plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multiple organs function score (MODS) of extensive burns
Time Frame: 48 hours during fluid resuscitation
48 hours during fluid resuscitation

Secondary Outcome Measures

Outcome Measure
Time Frame
Intra-abdominal pressure (IAP) of extensive burns
Time Frame: 48 hours during fluid resuscitation
48 hours during fluid resuscitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Director: Xueyong Li, MD, Department of Burn and Plastic Sugery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 30, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDLL-20100180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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