Clinical trial NCT02297659: Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure
Official title: Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Abdomen After Damage Control Laparotomy
Keywords: damage control
resuscitation
laparotomy
Lead sponsor: San Antonio Military Medical Center
Sponsor class: FED
First posted: 2014-11-21
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Damage control laparotomy (DCL) has proven to be a successful means to improve survival in severely injured patients.1-5 However, the consequences of not being able to close the fascia after the initial operation due to significant resuscitation leading to bowel and retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC) contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias, enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or standard crystalloid solutions after DCL and compare the time to PFC, rate of successful closure, and rate of complications associated with an open abdomen. The current failure rate of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using hypertonic saline.

Detailed description: The use of HTS after DCL may decrease the rate of failure to achieve PFC and reduce the number of complications associated with an open abdomen.

Research Questions:

1. Primary Objective: Is there a higher rate of PFC among patients who undergo DCL and temporary abdominal closure when using HTS versus standard crystalloid resuscitation?
2. Secondary Objectives: Does successful and faster PFC reduce ICU, ventilator and hospital days?
3. Does faster and more successful PFC result in lower morbidity to include enterocutaneous fistula (ECF), intra-abdominal abscess (IAA), abdominal wall hernia, and anastomotic failure?

DCL is a common procedure wounded warriors undergo due to blast and other blunt and penetrating mechanisms of injury. This results in a significant population of warriors at risk for all of the complications and comorbidities that accompany an open abdomen. Thus, finding ways to not only achieve PFC but also to decrease the time to PFC will reduce these unwanted events.

The protocol design is a multi-institutional, prospective, double blind, randomized controlled trial of patients who undergo DCL for abdominal trauma requiring temporary abdominal closure and return to operating room for definitive treatment. All participating facilities are Level I Trauma Centers. Currently, the standard of care for damage control resuscitation involves all intravenous fluid solutions utilized in this study; normal saline, Ringer's lactate, Plasmalyte, and 3% saline (HTS). However, the type of fluid is selected based on surgeon preference alone. Investigators will randomize patients to normal saline at a resuscitation rate of 30 cc/hr or to 3% saline (HTS) at a resuscitation rate of 30cc/hr which will be initiated upon arrival to the ICU.

Eligibility criteria: Inclusion Criteria:

* All admissions of trauma patients who sustain trauma necessitating damage control laparotomy.
* Male and female patients 18 years or older.

Exclusion Criteria:

* Children (\<18 years old), prisoners, or pregnant patients.
* Patients who have more than 1/3 loss of abdominal wall due to trauma.
* Patients with baseline serum sodium of \<120 mEq/L or \>155 mEq/L.

Primary outcomes:
measure: Number of participants who achieve primary fascial closure
timeFrame: 2 weeks
Secondary outcomes:
measure: number of ICU free days
timeFrame: 30 days
measure: number of enterocutaneous fistula
timeFrame: 90 days
measure: number of intra abdominal abscess
timeFrame: 90 days
measure: number of abdominal wall hernias
timeFrame: 90 days
measure: number of anastomotic failure
timeFrame: 90 days
measure: number of ventilator free days
timeFrame: 30 days
measure: number of hospital free days
timeFrame: 30 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
References:
citation: Harvin JA, Mims MM, Duchesne JC, Cox CS Jr, Wade CE, Holcomb JB, Cotton BA. Chasing 100%: the use of hypertonic saline to improve early, primary fascial closure after damage control laparotomy. J Trauma Acute Care Surg. 2013 Feb;74(2):426-30; discussion 431-2. doi: 10.1097/TA.0b013e31827e2a96.