Abdominal Injuries
Conditions
Keywords
Open abdomen, hypertonic saline solution, intensive care
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.
Interventions
DRUGSodium 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).
DRUGSodium 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).
Sponsors
Fundacion Clinica Valle del Lili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal wall closure | 7 days | Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluid Balance measured in cm3 | 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 | 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 | 7 days | Incidence of organ failure (defined as SOFA score greater than 2). |
| Mortality | 28 days | 28 day mortality rate |
Countries
Colombia
Outcome results
None listed