The unrestricted global effort to complete the COOL trial

Area of Science:

• Critical Care Medicine
• Surgical Innovation
• Clinical Trials

Background:

• Severe complicated intra-abdominal sepsis (SCIAS) presents a significant challenge with high mortality rates.
• Mortality in SCIAS stems from gastrointestinal tract disruption, systemic inflammation, and organ failure.
• Open abdomen (OA) with negative peritoneal pressure therapy (NPPT) is a potential therapeutic option to manage SCIAS complications.

Purpose of the Study:

• To assess the efficacy of open abdomen (OA) management with negative peritoneal pressure therapy (NPPT) in severe complicated intra-abdominal sepsis (SCIAS).
• To evaluate the hypothesis that NPPT attenuates systemic damage and improves survival in SCIAS patients.
• To expand the Closed Or Open after Laparotomy (COOL) trial globally, removing device restrictions.

Main Methods:

• The COOL trial is a large prospective randomized controlled trial comparing OA with NPPT to formal fascial closure.
• Eligible patients have intra-peritoneal contamination and septic shock or predicted adverse outcomes.
• The primary outcome is 90-day survival, aiming to inform global clinical practice.

Main Results:

• Initial recruitment was satisfactory but lower than anticipated.
• The steering committee and investigators aim to continue enrollment with increased global support to ensure definitive results.
• The trial is now device-agnostic, allowing for broader NPPT device use.

Conclusions:

• The COOL trial seeks to provide definitive evidence on the optimal management of SCIAS.
• Expanding the trial globally will enhance external validity and provide robust data on NPPT efficacy.
• The study aims to improve survival rates for patients with severe complicated intra-abdominal sepsis.