Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

• ClinicalTrials.gov Identifier: NCT01563991
• Recruitment Status: Completed
• First Posted: March 27, 2012
• Last Update Posted: March 30, 2017
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Luca Stocchi, The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Benign Neoplasm of Intestinal Tract; Primary Malignant Neoplasm of Intestinal Tract; Secondary Malignant Neoplasm of Intestinal Tract	Procedure: Normal fluid volume; Procedure: Reduced fluid volume	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery
• Study Start Date: February 2007
• Actual Primary Completion Date: April 18, 2012
• Actual Study Completion Date: April 18, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Morbidity [ Time Frame: 5-7 days ]
   Reduction in post-operative complications at the time of hospital discharge after the surgical episode

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

• Principal Investigator: Lucci Stocchi, MD; The Cleveland Clinic

More Information

• Responsible Party: Luca Stocchi, MD, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01563991
• Other Study ID Numbers: 07-016
• First Posted: March 27, 2012
• Last Update Posted: March 30, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Luca Stocchi, The Cleveland Clinic:

surgery; fluid; morbidity

Additional relevant MeSH terms:

Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases