Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01563991
First received: March 24, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 5-7 days ] [ Designated as safety issue: Yes ]
    Reduction in post-operative complications at the time of hospital discharge after the surgical episode


Estimated Enrollment: 186
Study Start Date: February 2007
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563991

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

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01563991     History of Changes
Other Study ID Numbers: 07-016
Study First Received: March 24, 2012
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
surgery
fluid
morbidity

Additional relevant MeSH terms:
Neoplasms
Intestinal Neoplasms
Neoplasms, Second Primary
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014