Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939613
• Other study ID #: TDLL-20100180
• Status: Completed
• Phase: N/A
• First received: August 30, 2013
• Last updated: September 5, 2013
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

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

Locations

Country	Name	City	State
China	Department of Burn and Plastic Surgery,Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple organs function score (MODS) of extensive burns		48 hours during fluid resuscitation	No
Secondary	Intra-abdominal pressure (IAP) of extensive burns		48 hours during fluid resuscitation	No