Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy

NCT02625701 | Completed Phase 3

• 1 other identifier: UGeneve - NAC09-022
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complication, Postoperative

Keywords

operative mortality; myocardial infarct, arrhythmia, heart failure, stroke; pneumonia, atelectasis, acute lung injury; surgical site infection; acute kidney injury; body weight

Outcome Measures

Primary Outcomes (1)

• composite index of serious postoperative adverse events

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

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

Secondary Outcomes (6)

• body weight changes (kg, postoperative value - preoperative value)

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

• fluid balance

  intra-operative and first 24hours after surgery

• Acute Kidney Injury based on RIFLE

  from the day before to 3 days after surgery

• Sequential Organ Failure Assessment (SOFA)

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

• tissue oximetry (%)

  intraoperative period, day of surgery

Study Arms (2)

Goal-Directed-Therapy (GDT)

EXPERIMENTAL

Besides the basal infusion of crystalloids at 3-6 ml/kg/h, colloids (200 ml) or crystalloids (200 ml) are given over 10 min in the presence of signs of absolute/relative hypovolemia as detected by a fall in cardiac output/stroke volume (CO/SV) or if Pressure Pulse Variation (PVV) or Stroke Volume Variation (SVV) exceeds 10-12%, particularly in the presence. Fluid filling is interrupted when SV fail to increase \> 10% (or PVV/SVV =\< 10%) Otherwise, vasopressors can be used to achieve appropriate mean arterial pressure (MAP\>70 mmHg, within ±20% of baseline). Blood losses are replaced with colloids (1:1) or crystalloids (2:1).

Procedure: Goal-directed therapy

Restrictive strategy

ACTIVE COMPARATOR

Crystalloids are given at a fixed rate of 3-6 ml/kg/h. Otherwise, vasopressors can be used to achieve appropriate MAP (\>70 mmHg, within ±20% of baseline). Blood losses are replaced with colloids (1:1) or crystalloids (2:1). Clinicians in charge of the patients are free to use hemodynamic parameters such as PVV or SVV, always attempting to limit the amount of fluid infusion and to maintain normovolemia

Procedure: Restrictive fluid therapy

Interventions

Goal-directed therapy PROCEDURE

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

Also known as: GDT

Goal-Directed-Therapy (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.

Restrictive strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital of Geneva, Department of Anesthesiology

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Postoperative Complications; Myocardial Infarction; Arrhythmias, Cardiac; Heart Failure; Stroke; Pneumonia; Pulmonary Atelectasis; Acute Lung Injury; Surgical Wound Infection; Acute Kidney Injury; Body Weight

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Wound Infection; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Study Officials

• Marc Licker, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients, clinical care givers and assessors are blinded to the the treatment (GDT or restrictive). Sealed enveloppes contain the patient' identification number. A person not involved in the study prepare the enveloppes with the identification number. Investigators who are assessing the postoperative study outcomes are blinded to the treatment arms
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: December 9, 2015
• Study Start: January 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

CH (1)