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

March 24, 2012
February 12, 2013
February 2007
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01563991 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes
Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Benign Neoplasm of Intestinal Tract
  • Primary Malignant Neoplasm of Intestinal Tract
  • Secondary Malignant Neoplasm of Intestinal Tract
  • Procedure: Normal fluid volume
    Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total
  • Procedure: Reduced fluid volume
    Subject receives 80 cc/ hr LR during the peri-operative period
  • Active Comparator: Standard fluid volume
    Subject receives normal fluid volume during peri-operative period
    Intervention: Procedure: Normal fluid volume
  • Experimental: Reduced Fluid Volume
    Subject receives a reduced fluid volume during the peri-operative period
    Intervention: Procedure: Reduced fluid volume
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
186
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01563991
07-016
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Lucci Stocchi, MD The Cleveland Clinic
The Cleveland Clinic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP