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Crystalloid resuscitation for Open Abdomen

N/A
Waitlist Available
Research Sponsored by San Antonio Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who achieve primary fascial closure
Secondary study objectives
number of ICU free days
number of abdominal wall hernias
number of anastomotic failure
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Crystalloid resuscitationActive Control2 Interventions
Patients to receive normal saline resuscitation at a rate of 30cc/hr.
Group II: Hypertonic saline resuscitationActive Control2 Interventions
Patients to receive 3% hypertonic saline resuscitation at a rate of 30cc/hr.

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Who is running the clinical trial?

San Antonio Military Medical CenterLead Sponsor
21 Previous Clinical Trials
4,527 Total Patients Enrolled
~28 spots leftby Dec 2025