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NCT Number: NCT02978430

Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

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.

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Key information

Conditions

Major Abdominal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computer-assisted GDFT

Device

Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.

Standard of care

Other

Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.

Primary outcomes

  1. Perioperative fluid administration

    Time frame: 24 hours

    Fluid balance during perioperative period

Secondary outcomes

  1. Length of hospitalisation

    Time frame: Every day up to 90 days after hospitalization

  2. Mortality rate

    Time frame: 30 days

  3. Transfusion of blood products during hospitalization

    Time frame: Every day up to 90 days post surgery

    In-hospital transfusion during hospitalization

  4. Hypotension incidence during surgery

    Time frame: 24 hours

    Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure)

  5. Need of vasopressor

    Time frame: 24 hours

    Use of vasopressors during the perioperative period

  6. Renal function - urea level

    Time frame: Every day up to 90 days after hospitalization

    Urea levels. Measured in a blood sample taken during hospitalization

  7. Renal function - creatinine level

    Time frame: Every day up to 90 days after hospitalization

    Creatinine levels. Measured in a blood sample taken during hospitalization

  8. Postoperative complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy in Major Abdominal Surgery: A Before and After Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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