Clinical Trial: Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients

Brief Summary: The purpose of this study is to determine whether hypertonic saline solution is effective in the resuscitation of traumatized patients undergone abdominal damage control surgery regarding early closure of the abdominal wall.

Detailed Summary: A double blind, controlled, randomized clinical trial will be 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, in terms closing time of abdominal cavity, fluids balance, abdominal hypertension and abdominal compartment syndrome occurrence, organ dysfunction and 28 days mortality.
Sponsor: Fundacion Clinica Valle del Lili

Current Primary Outcome: Abdominal wall closure [ Time Frame: 7 days ]

Proportion of patients in which closure of abdominal wall was made in the first 7 days after trauma.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fluid Balance measured in cm3 [ Time Frame: 72 hours ]

    Fluid balance during the first 72 hours after the trauma.

    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, in accordance with the SOFA scale compromising lung, kidney or heart) during the first 7 days following the trauma.
  • 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


Original Secondary Outcome: Same as current

Information By: Fundacion Clinica Valle del Lili

Dates:
Date Received: August 27, 2015
Date Started: December 2015
Date Completion: May 2018
Last Updated: December 22, 2015
Last Verified: December 2015