Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control (CELTA)
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|ClinicalTrials.gov Identifier: NCT02542241|
Recruitment Status : Terminated (lack of funds to continue recruitment)
First Posted : September 4, 2015
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Injuries||Drug: Sodium Chloride [3%] Drug: Sodium Chloride [0.9%]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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).
|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).
- 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.
- 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
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
|Fundacion Clinica Valle del Lili|
|Cali, Valle Del Cauca, Colombia|
|Principal Investigator:||Alberto F García, MD||Fundacion Clinica Valle del Lili|