This trial has been completed.

Conditions benign neoplasm of intestinal tract, primary malignant neoplasm of intestinal tract, secondary malignant neoplasm of intestinal tract
Treatments normal fluid volume, reduced fluid volume
Sponsor The Cleveland Clinic
Start date February 2007
End date April 2012
Trial size 186 participants
Trial identifier NCT01563991, 07-016


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
(Active Comparator)
Subject receives normal fluid volume during peri-operative period
normal fluid volume
Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total
Subject receives a reduced fluid volume during the peri-operative period
reduced fluid volume
Subject receives 80 cc/ hr LR during the peri-operative period

Primary Outcomes

time frame: 5-7 days

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery
Principal investigator Lucci Stocchi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.