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lack of funds to continue recruitment
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Chloride [3%] | Experimental |
| |
| Sodium Chloride [0.9%] | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Chloride [3%] | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal wall closure | Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto F GarcÃa, MD | Fundacion Clinica Valle del Lili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Clinica Valle del Lili | Cali | Valle del Cauca Department | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36624448 | Derived | Garcia AF, Manzano-Nunez R, Carrillo DC, Chica-Yanten J, Naranjo MP, Sanchez AI, Mejia JH, Ospina-Tascon GA, Ordonez CA, Bayona JG, Puyana JC. Hypertonic saline infusion does not improve the chance of primary fascial closure after damage control laparotomy: a randomized controlled trial. World J Emerg Surg. 2023 Jan 9;18(1):4. doi: 10.1186/s13017-023-00475-x. |
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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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| ID | Term |
|---|---|
| D000007 | Abdominal Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D012462 | Saline Solution, Hypertonic |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| Sodium Chloride [0.9%] | Drug | 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). |
|
|
| 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. | 7 days |
| Incidence of Organ Failure | Incidence of organ failure (defined as SOFA score greater than 2). | 7 days |
| Mortality | 28 day mortality rate | 28 days |
| D017670 |
| Sodium Compounds |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |