Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456703
Status:
WITHDRAWN
Last Update Posted:
2017-03-06
First Post:
2007-04-04
Brief Title:
Restricted Fluid Regimen in Open Abdominal Bowel Surgery
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Safety and Efficacy of Restricted Fluid Regimen in Open Abdominal Bowel Surgery
Status:
WITHDRAWN
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 10mlkghr the current standard of care for bowel surgery whereas those in the restricted group will receive 4mlkghour 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 patients 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
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 10mlkghr the current standard of care for bowel surgery whereas those in the restricted group will receive 4mlkghour 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None