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Completed

NCT Number: NCT01939613

Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

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%.

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Key information

Conditions

Burn Burns Wounds and Injuries

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Burn and Plastic Surgery,Tangdu Hospital

Xi'an, Shaanxi, 710038, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

colloids

Drug

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

Other names: frozen fresh plasma

Primary outcomes

  1. Multiple organs function score (MODS) of extensive burns

    Time frame: 48 hours during fluid resuscitation

Secondary outcomes

  1. Intra-abdominal pressure (IAP) of extensive burns

    Time frame: 48 hours during fluid resuscitation

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2013
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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