MedDataX Logo

Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

NCT ID: NCT01939613

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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%.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burn

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fluid resuscitation burn colloid, multiple organ dysfunction intra-abdominal pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parkland group

Extensive burn patients are resuscitated with Parkland formula.In the first 24h of resuscitation,crystalloids were infused as the main fluid.

No interventions assigned to this group

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.

colloids

Intervention Type DRUG

TMMU group allows for administration of colloids early,while Parkland group infuse colloids 24 h after burn injury.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

colloids

TMMU group allows for administration of colloids early,while Parkland group infuse colloids 24 h after burn injury.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

frozen fresh plasma

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Honghui Zhang

Mr Honghui Zhang

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xueyong Li, MD

Role: STUDY_DIRECTOR

Department of Burn and Plastic Sugery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Burn and Plastic Surgery,Tangdu Hospital

Xi'an, Shaanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TDLL-20100180

Identifier Type: -

Identifier Source: org_study_id