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. 2019 Dec 12;2019(12):CD012767. doi: 10.1002/14651858.CD012767.pub2

NCT02625701.

Trial name or title Perioperative fluid management: goal‐directed therapy versus restrictive approach: a randomized controlled trial
Methods Study type: parallel, single‐blinded (participants) RCT
Location: Geneva, Switzerland
Number of centres: NR
Duration of study: NR
Follow‐up: up to 15 weeks after date of surgery
Protocol: NCT02625701
Participants Inclusion criteria

  1. Adults (18 years and older)

  2. Elective non‐cardiac surgery (moderate‐high risk) lasting > 2 hours (gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)


Exclusion criteria

  1. End‐stage organ failure (haemofiltration/dialysis)

  2. Child‐Pugh class C or MELD score > 22

  3. Predicted forced expiratory volume < 30%; severe heart failure

  4. Life expectancy < 24 hours

  5. Psychiatric disorders or inability to give independent consent for the study


Total number of participants: NR
Characteristics: NR
Comorbidities, n (%): NR
Interventions Treatment groups

  1. RFT ‐ study "restrictive" group ‐ crystalloids are given at a fixed rate of 3 to 6 mL/kg/h. Otherwise, vasopressors can be used to achieve appropriate MAP ( > 70 mmHg, within ± 20% of baseline)

  2. GDFT ‐ study "goal‐directed therapy (GDT)" group ‐ besides basal infusion of crystalloids at 3 to 6 mL/kg/h, colloids (200 mL) or crystalloids (200 mL) are given over 10 minutes if pulse pressure variation (PPV) or stroke volume variation (SVV) exceeds 10% to 12%, with the aim of optimizing cardiac output. Otherwise, vasopressors can be used to achieve appropriate mean arterial pressure (MAP > 70 mmHg, within ± 20% of baseline)


Concomitant treatment in both groups

  1. Blood losses are replaced with colloids (1:1) or crystalloids (2:1)
Outcomes Primary outcome

  1. Composite index of serious postoperative adverse events (early postoperative major outcomes: mortality, cardiovascular, respiratory, renal, and infectious complications)


Secondary outcomes

  1. Body weight changes

  2. Fluid balance (amount of fluid (mL) infused, amount of fluid loss, change in body weight)

  3. Acute kidney injury based on RIFLE

  4. Sequential organ failure assessment (SOFA)

  5. Tissue oximetry
Starting date January 2012
Contact information Marc Licker; +41223827439; marc‐joseph.licker@hcuge.ch
Notes Funding: University Hospital, Geneva
Conflict of interest: NR
When we contacted study authors, we were informed that the study will be finished within a few months and the results will be published in the upcoming year