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NCT Number: NCT02625701

Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy

There is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient.

In this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource utilization in noncardiac surgical procedures (major-to-intermediate level of stress.

Two intraoperative fluid strategies will be compared: "Restrictive" vs. "goal-directed therapy (GDT)". In the GDT group, haemodynamic information will be obtained by a flow monitoring device coupled with standard heart rate and blood pressure monitoring.

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Key information

Conditions

Complication, Postoperative Acute Kidney Injury Acute Lung Injury Arrhythmias, Cardiac Body Weight Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Infarction Infections Ischemia Kidney Diseases Lung Diseases Lung Injury Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Postoperative Complications Pulmonary Atelectasis Renal Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stroke Surgical Wound Infection Urogenital Diseases Urologic Diseases Vascular Diseases Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Geneva, Department of Anesthesiology

Geneva, 1211, Switzerland

About this study

The rationale of minimizing body weight gain and avoiding unnecessary fluid compensation of the "third compartment" is now well justified and achievement of supra-normal oxygen delivery values is likely not necessary in most surgical patients. Therefore,it would be tempting to adopt fluid restriction protocols given the potentials of better wound healing, faster return of bowel function and shorter hospital stay after major surgical procedures.

Although dynamic flow indices of volume responsiveness have been validated in critically-ill patients, concerns have been raised regarding the risk of overzealous fluid administration in non-critically-ill patients undergoing elective surgery.

To date, RCTs comparing fluid regimen ("liberal" versus "restrictive" or "liberal" versus "GDT") have yielded controversial results with no consensus regarding appropriate fluid administration in the perioperative period. Interestingly, restrictive protocols have been associated with more frequent adverse events (e.g., nausea, vomiting) following minor surgical procedures and concerns have been raised regarding the possibility of tissue hypoperfusion leading to end-organ dysfunction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patient
  • elective noncardiac surgery (moderate-high-risk) lasting > 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)

Exclusion criteria

  • end-stage organ failure (hemofiltration/dialysis; Child-Pugh class C or MELD score >22; predicted forced expiratory volume < 30%, severe heart failure)
  • life expectancy < 24h
  • psychiatric disorders or unability to give independent consent to the study

Treatment and study plan

Goal-Directed Therapy

Procedure

Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)

Other names: GDT

Restrictive fluid therapy

Procedure

Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.

Primary outcomes

  1. composite index of serious postoperative adverse events

    Time frame: from date of surgery till hospital discharge or 30-day postoperative

    early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications

Secondary outcomes

  1. body weight changes (kg, postoperative value - preoperative value)

    Time frame: from date of surgery till hospital discharge, or 30-day postoperative

    comparison of body weight (preop versus postop value, kg)

  2. fluid balance

    Time frame: intra-operative and first 24hours after surgery

    amount of fluids (ml) infused, amount of fluid losses

    change in body weight

  3. Acute Kidney Injury based on RIFLE

    Time frame: from the day before to 3 days after surgery

    measurements of creatinine (preoperative, postoperative day 1, 2, 3 after surgery) and assessing the changes in glomerular filtration rate (%)

  4. Sequential Organ Failure Assessment (SOFA)

    Time frame: from date of surgery till hospital discharge, up to 15 weeks after date of surgery

    scoring the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems

  5. tissue oximetry (%)

    Time frame: intraoperative period, day of surgery

    Monitoring of oxygen delivery/utilization in the brain area with near-infra-red spectroscopy (NIRS)

  6. survival

    Time frame: survival 1-3 years after surgery

    patients (family, next of kin, doctor) are contacted by phone or mail

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Perioperative Fluid Management: Goal-Directed Therapy vs. Restrictive Approach, a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Dec 9, 2015
Registry last updated
Sep 12, 2019

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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