Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | January 2017 |
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.
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.
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.
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.
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.
We found this trial at
1
site
San Antonio, Texas
Principal Investigator: Valerie G Sams, MD
Phone: 859-230-0417
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