REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery

NCT02073162 | Completed Results DMC

• 1 other identifier: 13-1287
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Physicians differ in their approaches to surgical fluid therapy, with some preferring higher volumes and others lower volumes. Each approach has potential advantages and disadvantages. Currently, there is no compelling evidence that one approach is better than the other. This study tests whether giving a volume on the low end of the usual amount ("restrictive management") has a different rate of complications compared to a volume on the high end of the usual amount ("liberal management"). This study will compare liberal and restrictive fluid management to determine their effects on major complications after abdominal surgery. Those who take part in the study will be visited five times before and after surgery in the hospital. Once discharged from the hospital, participants will be called 4 times on the telephone. Preadmission Clinic/Preoperative Visit

• Sign the consent document
• Have blood drawn for standard preoperative tests (standard of care)
• Have an electrocardiogram (standard of care)
• Complete a questionnaire on disability (research) Day of Surgery
• Have blood drawn if not already done during the first visit (standard of care)
• Have an electrocardiogram if not already done during the first visit (standard of care)
• Be randomly assigned to either restrictive or liberal fluid management (research) Post-op Day 1
• Have an electrocardiogram done (research)
• Have blood drawn for standard tests (standard of care)
• Have a wound inspection, if there is a change of dressing (standard of care)
• Complete a questionnaire about your recovery (research) Post-op Day 3
• Have blood drawn for standard tests (standard of care) and c-reactive protein, which can indicate infection (for research).
• Have a wound inspection, if there is a change of dressing (standard of care)
• Complete a questionnaire about your recovery (research) Day of Discharge
• Have a wound inspection, if there is a change of dressing (standard of care) 30-Day Follow-up Phone Call
• Complete a questionnaire about your recovery (research)
• Complete a questionnaire about disability (research) 3 Month, 6-Month, and 12-Month Follow-up Phone Calls
• Complete a questionnaire about disability (research)

Conditions

Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Disability-free Survival

  Disability was defined as a persistent impairment in health status (lasting ≥6 months), as measured by a score of at least 24 points on the WHODAS questionnaire, which reflects a disability level of at least 25% (the threshold point between "disabled" and "not disabled").

  1 year

Secondary Outcomes (11)

• Number of Participants With Acute Kidney Injury

  90 days

• Number of Participants With a Composite of Mortality or Major Septic Complications

  30-day

• Number of Participants With Surgical-site Infection

  Indexed hospital stay

• Number of Participants With Sepsis

  Indexed hospital stay

• Number of Participants With Anastomotic Leak

  Indexed hospital stay

Study Arms (2)

Liberal group

ACTIVE COMPARATOR

At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs

Procedure: Major Abdominal Surgery

Restrictive group

EXPERIMENTAL

At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids

Procedure: Major Abdominal Surgery

Interventions

Major Abdominal Surgery PROCEDURE

•All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)

Liberal group; Restrictive group

Eligibility Criteria

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

You may qualify if:

• adults (≥18 years) undergoing elective major surgery and providing informed consent
• all types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
• at increased risk of postoperative complications, defined as at least one of the following criteria:
• age ≥70 years
• known or documented history of coronary artery disease
• known or documented history of heart failure
• diabetes currently treated with an oral hypoglycaemic agent and/or insulin
• preoperative serum creatinine \>200 μmol/L (\>2.8 mg/dl)
• morbid obesity (BMI ≥35 kg/m2)
• preoperative serum albumin \<30 g/L
• anaerobic threshold (if done) \<12 mL/kg/min
• or two or more of the following risk factors:
• ASA 3 or 4
• chronic respiratory disease
• obesity (BMI 30-35 kg/m2)

You may not qualify if:

• urgent or time-critical surgery
• ASA physical status 5 - such patients are not expected to survive with or without surgery, and their underlying illness is expected to have an overwhelming effect on outcome (irrespective of fluid therapy)
• chronic renal failure requiring dialysis
• pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
• liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
• minor or intermediate surgery, such as laparoscopic cholecystectomy, transurethral resection of the prostate, inguinal hernia repair, splenectomy, closure of colostomy - each of these are typically "minor" surgery with minimal IV fluid requirements, generally low rates of complications and mostly very good survival.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Dr. Daniel Sessler
• Organization: The Cleveland Clinic Foundation

ds@or.org

216-444-4900

Study Officials

• Andrea Kurz

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 27, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: February 1, 2018
• Last Updated: October 31, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-10

Locations

US (1)