Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

Phase 2

Completed

• Conditions: Major Abdominal Surgery
• Interventions: Device: Computer-assisted GDFT; Other: Standard of care

• Registration Number: NCT02978430
• Lead Sponsor: Erasme University Hospital

Brief Summary

The aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.

Detailed Description

Fluid therapy is one of the main tools used in anesthesiology to maintain adequate hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to decrease post-operative complications. The main inconvenience of protocol based therapy is its technical complexity which requires considerable time, attention, and vigilance. GDFT assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer preload independent state and could increase clinician adherence to protocol. To this day no study has compared closed-loop assisted GDFT to standard of care.

Goal:

This study compares the results of the study entitled "Crystalloids or Colloids for Goal directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) to a standard of care group (started retrospectively before the first included patient of the above study) where fluid therapy is based only on static variables (e.g. arterial pressure, heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the same population undergoing the same types of surgery.

Hypothesis:

A protocolized approach using computer-assisted GDFT when compared to standard of care is associated with less fluid administration and less blood transfusions.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2016-11
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Computer-assisted GDFT	Computer-assisted GDFT	This group consists of patients undergoing major abdominal surgery where fluid management is carried out with a closed-loop (automated) system to deliver fluid by a goal-directed fluid therapy (GDFT) standardized protocol. Confer: "Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999)
Standard of care	Standard of care	This group (started retrospectively before the first included patient of the closed-loop goal-directed fluid therapy group) consists of patients undergoing major abdominal surgery where fluid management is carried out based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output).

Primary Outcome Measures

Name	Time	Method
Perioperative fluid administration	24 hours	Fluid balance during perioperative period

Secondary Outcome Measures

Name	Time	Method
Transfusion of blood products during hospitalization	Every day up to 90 days post surgery	In-hospital transfusion during hospitalization
Mortality rate	30 days
Length of hospitalisation	Every day up to 90 days after hospitalization
Hypotension incidence during surgery	24 hours	Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure)
Need of vasopressor	24 hours	Use of vasopressors during the perioperative period
Renal function - urea level	Every day up to 90 days after hospitalization	Urea levels. Measured in a blood sample taken during hospitalization
Renal function - creatinine level	Every day up to 90 days after hospitalization	Creatinine levels. Measured in a blood sample taken during hospitalization
Postoperative complications	Every day up to 90 days after hospitalization	Major complications included cardiac (acute coronary syndrome/ arrhythmia), pulmonary (embolism/edema), gastrointestinal (bowel and surgical anastomotic leak/internal or external fistulas/peritoneal effusions), renal (renal failure requiring dialysis), infectious (peritonitis/ sepsis), coagulation (bleeding), wound dehiscence, stroke, reoperation, readmission, and death. Minor complications included unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus progressive, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.

Trial Locations

Locations (1)

Erasme University Hospital; 🇧🇪 Brussels, Belgium