Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02978430
• Date of registration: 22/11/2016
• Prospective Registration: No
• Primary sponsor: Erasme University Hospital
• Public title: Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy
• Scientific title: Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy in Major Abdominal Surgery: A Before and After Study
• Date of first enrolment: April 2015
• Target sample size: 260
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02978430
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients (over the age of 18) undergoing elective major abdominal surgery that
is expected to take longer than 3 hours and requiring general anesthesia.

Exclusion Criteria:

- Patients under 18 years of age

- Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring

- Patients with arrhythmia and/or atrial fibrillation

- Patients who are allergic to HES (hydroxyethyl starch)

- Patients with renal insufficiency (serum creatinine of >2 mg/ml) or hepatic
dysfunction (liver enzymes >1.5)

- Patients who has coagulation disorders (values higher than 1.5x normal values)

- Patients without the capacity to give written informed consent or refusal of consent

- Pregnancy at time of enrollment.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Major Abdominal Surgery

Intervention(s)

Device: Computer-assisted GDFT

Other: Standard of care

Primary Outcome(s)

Perioperative fluid administration [Time Frame: 24 hours]

Secondary Outcome(s)

Postoperative complications [Time Frame: Every day up to 90 days after hospitalization]

Mortality rate [Time Frame: 30 days]

Hypotension incidence during surgery [Time Frame: 24 hours]

Length of hospitalisation [Time Frame: Every day up to 90 days after hospitalization]

Renal function - creatinine level [Time Frame: Every day up to 90 days after hospitalization]

Renal function - urea level [Time Frame: Every day up to 90 days after hospitalization]

Need of vasopressor [Time Frame: 24 hours]

Transfusion of blood products during hospitalization [Time Frame: Every day up to 90 days post surgery]

Secondary ID(s)

P2016/334

Source(s) of Monetary Support

Please refer to primary and secondary sponsors