Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery

Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.

Study Overview

• Status: Completed
• Conditions: Benign Neoplasm of Intestinal Tract; Primary Malignant Neoplasm of Intestinal Tract; Secondary Malignant Neoplasm of Intestinal Tract
• Intervention / Treatment: Procedure: Normal fluid volume; Procedure: Reduced fluid volume

Detailed Description

The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 18 years or older
• ASA I-III
• Ability to provide informed consent
• Creatinine less than or equal to 1.3 mg/mL)

Exclusion Criteria:

Patients younger than 18 years old

• ASA IV or higher
• Urgent or emergent surgery
• Mental disease or addictive disorders impairing ability to provide informed consent
• Renal insufficiency (Cr greater than 1.3 mg/mL)
• Significant language barriers
• Cirrhosis causing ascites
• NYHA III or IV, EF less than 25%
• Use of intraoperative epidural anesthesia
• Uncontrolled diabetes
• Uncontrolled hypertension in the opinion of the enrolling surgeon
• ETOH consumption greater than 35 drinks weekly
• Cachexia or absolute neutrophil count of less than 1,200/mm3
• Existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard fluid volume; Subject receives normal fluid volume during peri-operative period	Procedure: Normal fluid volume; Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total
Experimental: Reduced Fluid Volume; Subject receives a reduced fluid volume during the peri-operative period	Procedure: Reduced fluid volume; Subject receives 80 cc/ hr LR during the peri-operative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Reduction in post-operative complications at the time of hospital discharge after the surgical episode	5-7 days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Lucci Stocchi, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): April 18, 2012
• Study Completion (Actual): April 18, 2012

Study Registration Dates

• First Submitted: March 24, 2012
• First Submitted That Met QC Criteria: March 26, 2012
• First Posted (Estimate): March 27, 2012

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: surgery; morbidity; fluid
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Neoplasms; Intestinal Neoplasms
• Other Study ID Numbers: 07-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No