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Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

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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

Tracking Information
First Submitted Date August 30, 2013
First Posted Date September 11, 2013
Last Update Posted Date September 11, 2013
Study Start Date July 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2013)
Multiple organs function score (MODS) of extensive burns [ Time Frame: 48 hours during fluid resuscitation ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 5, 2013)
Intra-abdominal pressure (IAP) of extensive burns [ Time Frame: 48 hours during fluid resuscitation ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients
Official Title Colloid Improves Organ Function by Reducing the Elevation of Intra-abdominal Pressure in Resuscitation of Critical Burn Patients
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 Type Observational [Patient Registry]
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Days
Biospecimen Not Provided
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.
Condition Burn
Intervention 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
Study Groups/Cohorts
  • 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.
    Intervention: Drug: colloids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 5, 2013)
47
Original Actual Enrollment Same as current
Actual Study Completion Date July 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01939613
Other Study ID Numbers TDLL-20100180
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Honghui Zhang, Tang-Du Hospital
Study Sponsor Tang-Du Hospital
Collaborators Not Provided
Investigators
Study Director: Xueyong Li, MD Department of Burn and Plastic Sugery
PRS Account Tang-Du Hospital
Verification Date September 2013