Back to resultsHypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control (CELTA)
Primary Purpose
Abdominal Injuries
Status
Terminated
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Sodium Chloride [3%]
Sodium Chloride [0.9%]
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Injuries focused on measuring Open abdomen, hypertonic saline solution, intensive care
Eligibility 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.
Sites / Locations
- Fundacion Clinica Valle del Lili
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sodium Chloride [3%]
Sodium Chloride [0.9%]
Arm Description
Outcomes
Primary Outcome Measures
Abdominal wall closure
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
Secondary Outcome Measures
Fluid Balance measured in cm3
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
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
Incidence of organ failure (defined as SOFA score greater than 2).
Mortality
28 day mortality rate
Full Information
NCT ID
NCT02542241
First Posted
August 27, 2015
Last Updated
June 8, 2020
Sponsor
Fundacion Clinica Valle del Lili
1. Study Identification
Unique Protocol Identification Number
NCT02542241
Brief Title
Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control
Acronym
CELTA
Official Title
Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
lack of funds to continue recruitment
Study Start Date
November 27, 2015 (undefined)
Primary Completion Date
September 4, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinica Valle del Lili
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Injuries
Keywords
Open abdomen, hypertonic saline solution, intensive care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Chloride [3%]
Arm Type
Experimental
Arm Title
Sodium Chloride [0.9%]
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride [3%]
Other Intervention Name(s)
Hypertonic Saline Solution, NaCl
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride [0.9%]
Other Intervention Name(s)
Physiologic Saline Solution, Normal Saline
Intervention Description
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).
Primary Outcome Measure Information:
Title
Abdominal wall closure
Description
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Fluid Balance measured in cm3
Description
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.
Time Frame
72 hours
Title
Incidence of Abdominal compartment syndrome
Description
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.
Time Frame
7 days
Title
Incidence of Organ Failure
Description
Incidence of organ failure (defined as SOFA score greater than 2).
Time Frame
7 days
Title
Mortality
Description
28 day mortality rate
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto F García, MD
Organizational Affiliation
Fundacion Clinica Valle del Lili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Clinica Valle del Lili
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control
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