Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 12, 2017
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new way to manage patients during major abdominal surgeries, specifically focusing on how to ensure they receive the right amount of fluids and oxygen to support their bodies. The study compares the standard care method with a new approach called the NICE protocol, which aims to better match patients' needs. Participants will be divided into three groups: one receiving standard care, one following the NICE protocol, and another using a special method that measures how well the body uses oxygen. The goal is to improve patient outcomes by carefully managing fluid balance during surgery.
To be eligible for this trial, participants must be at least 18 years old and able to provide written consent. They should be scheduled for major abdominal surgeries lasting three hours or more. However, certain individuals will not be able to participate, including those with severe heart conditions, pregnant women, or those undergoing specific types of surgeries like liver or emergency procedures. If you join the study, you can expect to be monitored closely during your surgery and receive care tailored to your individual needs, which could help improve your recovery after the procedure.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • patients aged \> 18 years
- • acquisition of written informed consent
- • Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours
- Exclusion Criteria:
- • Absolute contraindication to CVC placement
- • pregnant women
- • hepatic surgery
- • laparoscopic surgery
- • Major vascular surgery
- • Dialysis treatment and kidney transplant surgery
- • Severe heart failure (EF ≤ 35%)
- • Emergency surgery
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Antonio M Dell'Anna, MD
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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