Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

Benign Neoplasm of Intestinal Tract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563991
• Other study ID #: 07-016
• Status: Completed
• Phase: N/A
• First received: March 24, 2012
• Last updated: March 28, 2017
• Start date: February 2007
• Est. completion date: April 18, 2012

Study information

• Verified date: March 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: April 18, 2012
• Est. primary completion date: April 18, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Neoplasm of Intestinal Tract
• Intestinal Neoplasms
• Neoplasms
• Neoplasms, Second Primary
• Primary Malignant Neoplasm of Intestinal Tract
• Secondary Malignant Neoplasm of Intestinal Tract

Intervention

Procedure:
• Normal fluid volume
Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total
• Reduced fluid volume
Subject receives 80 cc/ hr LR during the peri-operative period

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Reduction in post-operative complications at the time of hospital discharge after the surgical episode	5-7 days