Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

NCT01563991 | Completed

• 1 other identifier: 07-016
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

surgery; fluid; morbidity

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Reduction in post-operative complications at the time of hospital discharge after the surgical episode

  5-7 days

Study Arms (2)

Standard fluid volume

ACTIVE COMPARATOR

Subject receives normal fluid volume during peri-operative period

Procedure: Normal fluid volume

Reduced Fluid Volume

EXPERIMENTAL

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

Procedure: Reduced fluid volume

Interventions

Normal fluid volume PROCEDURE

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

Standard fluid volume

Reduced fluid volume PROCEDURE

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

Reduced Fluid Volume

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Lucci Stocchi, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2012
• First Posted: March 27, 2012
• Study Start: February 1, 2007
• Primary Completion: April 18, 2012
• Study Completion: April 18, 2012
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)