Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01939613
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
Honghui Zhang, 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%.

Condition or disease Intervention/treatment
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 47 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Colloid Improves Organ Function by Reducing the Elevation of Intra-abdominal Pressure in Resuscitation of Critical Burn Patients
Study Start Date : July 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Group/Cohort 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 Name: frozen fresh plasma




Primary Outcome Measures :
  1. Multiple organs function score (MODS) of extensive burns [ Time Frame: 48 hours during fluid resuscitation ]

Secondary Outcome Measures :
  1. Intra-abdominal pressure (IAP) of extensive burns [ Time Frame: 48 hours during fluid resuscitation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939613


Locations
Layout table for location information
China, Shaanxi
Department of Burn and Plastic Surgery,Tangdu Hospital
Xi'an, Shaanxi, China, 710038
Sponsors and Collaborators
Tang-Du Hospital
Investigators
Layout table for investigator information
Study Director: Xueyong Li, MD Department of Burn and Plastic Sugery

Additional Information:

Layout table for additonal information
Responsible Party: Honghui Zhang, Mr Honghui Zhang, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT01939613     History of Changes
Other Study ID Numbers: TDLL-20100180
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
Keywords provided by Honghui Zhang, Tang-Du Hospital:
fluid resuscitation
burn
colloid,
multiple organ dysfunction
intra-abdominal pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Burns
Wounds and Injuries