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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01563991
Other study ID # 07-016
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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