Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

Sponsor

Tang-Du Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01939613

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Burn	Drug: colloids

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

47 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Multiple organs function score (MODS) of extensive burns [48 hours during fluid resuscitation]

Secondary Outcome Measures

Intra-abdominal pressure (IAP) of extensive burns [48 hours during fluid resuscitation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.