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Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control (CELTA)

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: NCT02542241
Recruitment Status : Terminated (lack of funds to continue recruitment)
First Posted : September 4, 2015
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Alberto Federico García, Fundacion Clinica Valle del Lili

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date June 11, 2020
Study Start Date  ICMJE November 27, 2015
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
Abdominal wall closure [ Time Frame: 7 days ]
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
Abdominal wall closure [ Time Frame: 7 days ]
Proportion of patients in which closure of abdominal wall was made in the first 7 days after trauma.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • Fluid Balance measured in cm3 [ Time Frame: 72 hours ]
    Fluid balance during the first 72 hours after injury. Defined as the difference between the amount of fluids taken into the body and the amount excreted or lost. Input includes oral fluids, infused intravenous fluids and blood products. Output includes fluid loss as urine, emesis and wound drainage among others.
  • Incidence of Abdominal compartment syndrome [ Time Frame: 7 days ]
    Incidence of abdominal compartment syndrome (defined as sustained intra-abdominal pressure > 20 mmHg, accompanied by new organ dysfunction, defined as a score > 2, under the SOFA scale compromising lung, kidney, or heart) during the first 7 days after injury.
  • Incidence of Organ Failure [ Time Frame: 7 days ]
    Incidence of organ failure (defined as SOFA score greater than 2).
  • Mortality [ Time Frame: 28 days ]
    28 day mortality rate
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • Fluid Balance measured in cm3 [ Time Frame: 72 hours ]
    Fluid balance during the first 72 hours after the trauma. Defined as the difference between the amount of fluids taken into the body and the amount excreted or lost. Input includes oral fluids, infused intravenous fluids and blood products. Output includes fluid loss as urine, emesis and wound drainage among others.
  • Incidence of Abdominal compartment syndrome [ Time Frame: 7 days ]
    Incidence of abdominal compartment syndrome (defined as sustained intra-abdominal pressure > 20 mmHg, accompanied by new organ dysfunction, defined as a score > 2, in accordance with the SOFA scale compromising lung, kidney or heart) during the first 7 days following the trauma.
  • Incidence of Organ Failure [ Time Frame: 7 days ]
    Incidence of organ failure (defined as SOFA score greater than 2).
  • Mortality [ Time Frame: 28 days ]
    28 day mortality rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control
Official Title  ICMJE Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients
Brief Summary This study aimed to determine whether hypertonic saline solution is effective in the resuscitation of injured patients undergoing abdominal damage control surgery regarding early closure of the abdominal wall.
Detailed Description A double-blind, controlled, randomized clinical trial was conducted to determine the impact of an infusion of hypertonic saline 3% vs. isotonic saline 0.9% at a dose of 50 mL/hr for the first 72 hours in patients with abdominal trauma requiring damage control surgery regarding some clinically relevant outcomes. These outcomes were: The timing of abdominal cavity closure, fluids balance, abdominal hypertension, and abdominal compartment syndrome occurrence, organ dysfunction, and 28 days' mortality.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Injuries
Intervention  ICMJE
  • Drug: Sodium Chloride [3%]
    Patients in this arm will receive an intravenous infusion of 3% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).
    Other Names:
    • Hypertonic Saline Solution
    • NaCl
  • Drug: Sodium Chloride [0.9%]
    Patients in this arm will receive an intravenous infusion of 0.9% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).
    Other Names:
    • Physiologic Saline Solution
    • Normal Saline
Study Arms  ICMJE
  • Experimental: Sodium Chloride [3%]
    Intervention: Drug: Sodium Chloride [3%]
  • Active Comparator: Sodium Chloride [0.9%]
    Intervention: Drug: Sodium Chloride [0.9%]
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  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 8, 2020)
52
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2015)
400
Actual Study Completion Date  ICMJE September 4, 2018
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Abdominal trauma requiring damage control surgery.
  • Acceptance by the patient or by a proxy to be included in the trial.

Exclusion Criteria:

  • Concomitant severe head trauma, defined by a Glasgow score <9, before receiving sedation or by the presence of cerebral edema or intracranial injury on a CT-scan.
  • Pregnancy
  • Patient not included 4 hours or more after damage control surgery.
  • Damage control laparotomy performed for other indications other than trauma.
  • Not index damage control laparotomy
  • No acceptance to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02542241
Other Study ID Numbers  ICMJE 00877
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The individual participant data contained in the datasets generated and/or analyzed for the current study are not publicly available as recommended by the local ethical and research committee involving human beings (Fundación Valle del Lili, Cali, Colombia) but could be available from the corresponding author on reasonable request and under prior approval by such committee.
Responsible Party Alberto Federico García, Fundacion Clinica Valle del Lili
Study Sponsor  ICMJE Fundacion Clinica Valle del Lili
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alberto F García, MD Fundacion Clinica Valle del Lili
PRS Account Fundacion Clinica Valle del Lili
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP