Restricted Fluid Regimen in Open Abdominal Bowel Surgery

This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00456703
First received: April 4, 2007
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the patients to multiorgan dysfunction, prolong hospital stay and increase postoperative morbidity. The main aim of the study is to assess the safety and feasibility of restricted fluid regimen in open abdominal bowel surgery.


Condition Intervention
Bowel Surgery
Other: intraoperative fluid management
Other: fluid restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Restricted Fluid Regimen in Open Abdominal Bowel Surgery

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • mixed venous oxygen saturation, acid bases, hemodynamics [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound infection and length of hospital stay [ Time Frame: during the hospital admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: restriction
In this group, the fluids will be restricted compared to a standard procedure
Other: intraoperative fluid management
fluid restriction
Other: fluid restriction
restriction of fluids

Detailed Description:

This is a randomized, prospective controlled trial in patients (ASA I-III) undergoing open abdominal surgical procedures in a single center. This study will be done in two phases. The first phase is designed to evaluate and prove the safety of restricted fluid regimens in maintaining tissue perfusion using a central venous oximetric catheter and arterial blood gas analysis. In the second phase of the study, we plan to mimic the usual clinical practice without the central venous oximetric catheter and arterial lines (invasive monitors) and the postoperative total morbidity will be compared between the liberal and restricted fluid regimens.

In the first phase of the study, 90 patients coming in for open bowel surgery will be randomized to three groups using a random number generator. All patients will receive a standard bowel prep regimen (Go-Lyte-half a liter the night before surgery). Group A will receive current standard of care (liberal fluid therapy), Group B and C will receive restricted fluid regimens. All patients will receive 500 cc of intravenous fluids (lactated ringers in Group A and B, 6% hetastarch in Group C) in the preoperative holding area to correct preoperative fluid deficits due to fasting and bowel preparation. Patients younger than 18 years, ASA IV or V, pregnant patients, those with coagulopathy, renal insufficiency, unstable angina, unstable congestive heart failure, and those with contraindication to central venous pressure catheter insertion will be excluded from the study.

After instituting anesthesia monitors, patients will be anesthetized with a standard anesthetic regimen. An arterial line and a central venous catheter with oximetric capability will be inserted in all three groups. A baseline blood gas will be drawn to note the base excess, lactate levels and the hematocrit at the start of surgery. Parameters like heart rate, blood pressure, central venous pressure, mixed venous oxygen saturation and arterial oxygen saturation and urine output will be continuously monitored. Both the regimens will be started in the operating room and continued into the postoperative period until they resume their oral intake. Patients in the liberal group will receive (10ml/kg/hr) the current standard of care for bowel surgery whereas those in the restricted group will receive 4ml/kg/hour. Post induction hemodynamic instability will be treated with ephedrine and phenylephrine at the discretion of the anesthesiologist in charge.

Intraoperative treatment of tachycardia, hypotension in both the groups will be treated using a standard fluid regimen algorithm (appendix A). All patients will receive the same postoperative fluid regimens as the current standard of care. Postoperative morbidity evaluation (appendix B) will be done at patient's discharge from the hospital. The data entry will be prospectively done during their hospital stay. The accuracy of the data will be checked by one of the study investigators.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-III patients coming in for open abdominal bowel surgery

Exclusion Criteria:

  • Coagulopathy,
  • Pregnancy,
  • Renal insufficiency,
  • Contraindications for placing a central line,
  • ASA IV and V,
  • Age less than 18years
  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: NCT00456703

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Balachundhar Subramaniam, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Balachundhar Subramaniam, BIDMC
ClinicalTrials.gov Identifier: NCT00456703     History of Changes
Other Study ID Numbers: 2006-P-000144
Study First Received: April 4, 2007
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
fluids,
restriction,
infection,
bowel surgery,
open abdominal

ClinicalTrials.gov processed this record on August 18, 2014