Major Abdominal Surgery
Conditions
Keywords
Fluid therapy, Anesthesiology, Major surgery, Goal-directed fluid therapy, Fluid responsiveness, Closed-loop system
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.
Interventions
DEVICEComputer-assisted GDFT
Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.
OTHERStandard of care
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.
Sponsors
Erasme University Hospital
Study design
Allocation
NON_RANDOMIZED
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative fluid administration | 24 hours | Fluid balance during perioperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 30 days | — |
| Transfusion of blood products during hospitalization | Every day up to 90 days post surgery | In-hospital transfusion during hospitalization |
| Hypotension incidence during surgery | 24 hours | Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure) |
| Length of hospitalisation | Every day up to 90 days after hospitalization | — |
| 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. |
| Need of vasopressor | 24 hours | Use of vasopressors during the perioperative period |
Countries
Belgium
Outcome results
None listed