Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

NCT ID: NCT01563991

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2012-04-18

Brief Summary

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.

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.

Conditions

Benign Neoplasm of Intestinal Tract; Primary Malignant Neoplasm of Intestinal Tract; Secondary Malignant Neoplasm of Intestinal Tract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard fluid volume

Subject receives normal fluid volume during peri-operative period

Group Type: ACTIVE_COMPARATOR

Normal fluid volume

Intervention Type: PROCEDURE

Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total

Reduced Fluid Volume

Subject receives a reduced fluid volume during the peri-operative period

Group Type: EXPERIMENTAL

Reduced fluid volume

Intervention Type: PROCEDURE

Subject receives 80 cc/ hr LR during the peri-operative period

Interventions

Normal fluid volume

Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total

Intervention Type: PROCEDURE

Reduced fluid volume

Subject receives 80 cc/ hr LR during the peri-operative period

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Luca Stocchi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucci Stocchi, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

07-016

Identifier Type: -

Identifier Source: org_study_id