Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

Completed

• Conditions: Burn
• Interventions: Drug: colloids

• Registration Number: NCT01939613
• Lead Sponsor: Tang-Du Hospital

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%.

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 Timeline

• Study Start: 2010-07
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Study First Submitted: 2013-08-30
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Study First Posted: 2013-09-11
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TMMU group	colloids	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.

Primary Outcome Measures

Name	Time	Method
Multiple organs function score (MODS) of extensive burns	48 hours during fluid resuscitation

Secondary Outcome Measures

Name	Time	Method
Intra-abdominal pressure (IAP) of extensive burns	48 hours during fluid resuscitation

Trial Locations

Locations (1)

Department of Burn and Plastic Surgery,Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China