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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

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.

Condition or disease Intervention/treatment Phase
Abdominal Injuries Drug: Sodium Chloride [3%] Drug: Sodium Chloride [0.9%] Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients
Study Start Date : November 27, 2015
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium Chloride [3%] 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

Active Comparator: Sodium Chloride [0.9%] 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. Incidence of Organ Failure [ Time Frame: 7 days ]
    Incidence of organ failure (defined as SOFA score greater than 2).

  4. Mortality [ Time Frame: 28 days ]
    28 day mortality rate



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02542241


Locations
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Colombia
Fundacion Clinica Valle del Lili
Cali, Valle Del Cauca, Colombia
Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
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Principal Investigator: Alberto F García, MD Fundacion Clinica Valle del Lili
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Responsible Party: Alberto Federico García, MD., Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier: NCT02542241    
Other Study ID Numbers: 00877
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alberto Federico García, Fundacion Clinica Valle del Lili:
Open abdomen
hypertonic saline solution
intensive care
Additional relevant MeSH terms:
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Abdominal Injuries
Wounds and Injuries
Pharmaceutical Solutions