NCT01939613

Brief Summary

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

2.9 years

First QC Date

August 30, 2013

Last Update Submit

September 5, 2013

Conditions

Keywords

fluid resuscitationburncolloid,multiple organ dysfunctionintra-abdominal pressure

Outcome Measures

Primary Outcomes (1)

  • Multiple organs function score (MODS) of extensive burns

    48 hours during fluid resuscitation

Secondary Outcomes (1)

  • Intra-abdominal pressure (IAP) of extensive burns

    48 hours during fluid resuscitation

Study Arms (2)

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

Interventions

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

Also known as: frozen fresh plasma
TMMU group

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Burn and Plastic Surgery,Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Burns

Interventions

Colloids

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Xueyong Li, MD

    Department of Burn and Plastic Sugery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr Honghui Zhang

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 11, 2013

Study Start

July 1, 2010

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations