Goal Directed Fluid Therapy and Postoperative Ileus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01818375
First received: March 21, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.

It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.


Condition Intervention
Postoperative Ileus
Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided
Other: Standard fluid therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Primary postoperative ileus (POI) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]

    Patients will be considered having primary POI if at least one symptom, for each of the following criteria, will be reported:

    i. vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet.



Secondary Outcome Measures:
  • Intraoperative hemodynamic measurements [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Systolic blood pressure; diastolic blood pressure; mean arterial blood pressure; heart rate; flow-time corrected (FTc); stroke distance (SD); Peak velocity (PV); stroke volume (SV); stroke index (SVI); cardiac output (CO); cardiac Index (CI)

  • Intraoperative and postoperative fluids and blood products required [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Vasoactive agents required [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Urinary output [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Intraoperative and postoperative urinary output [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Intraoperative and Postoperative opioid consumption [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Intraoperative opioid administration and postoperative opioid consumption

  • Postoperative nausea and vomiting (PONV) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Time spent out of bed [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Postoperative complications (Clavien Classification) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Patients' weight [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Quality of surgical recovery score [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Readiness to be discharged [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    : according to the colorectal pathway, hospital discharge is planned on postoperative day 3. Patients will be discharged if afebrile, able to tolerate oral diet, pain is controlled (NRS < 4), and able to ambulate

  • Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Goal Directed Fluid Therapy (GDFT)

During surgery, patients in the Goal Directed Fluid Therapy (GDFT) will receive:

  1. maintenance infusion of intravenous infusion of ringer lactate at a rate of 1.5 ml/Kg/hr to compensate insensible blood loss and fluid shift during surgery as recommended by perioperative fluid management guidelines for patients undergoing surgery with an enhanced recovery program and receiving a GDFT approach;
  2. intraoperative intravenous boluses of colloids (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride-Voluven) guided by an algorithm based on Esophageal Doppler (ED) estimation of the stroke volume (SV) provided by the manufacture, and also used in other clinical trials.
Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided
Other Name: Esophageal doppler-Deltex Medical
Active Comparator: Standard Fluid Therapy
During surgery, patients will receive a maintenance infusion of intravenous infusion of ringer lactate as recommended by international guidelines and anesthesia text-books (Standard Fluid Therapy). In the Standard Fluid Therapy arm, the Esophageal Doppler (ED) monitor will be turned away from the anesthesia care provider, and the screen will be covered with an opaque card. The ED variables will be collected by an independent research personnel. Hemodynamic variables triggering extra fluid administration (Ringer Lactate or Voluven) will be decided based on the clinical judgment of the anesthetist in charge and will include: urinary output less than 0.5/ml/kg/hr, an increase in heart rate more than 20% above baseline or more than 110 beats/min, a decrease in mean systolic blood pressure less than 20% below baseline or less than 90 mmHg and intraoperative blood loss. Boluses of 200 ml of intravenous fluid will be administered until the above targets will be restored
Other: Standard fluid therapy
Other Name: Intravenous infusion as recommended by international guidelines and anesthesia text-books

Detailed Description:

Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)

Two arms:

GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.

Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.

ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.

  Eligibility

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

Inclusion Criteria:

  • All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program

Exclusion Criteria:

  1. Age <18 yr
  2. Emergency surgery
  3. Patients who do not understand, read or communicate in either French or English
  4. Patients who had undergone esophageal or gastric surgery
  5. Esophageal pathology (esophageal varices or cancer)
  6. Patients with coarctation of the aorta or aortic stenosis
  7. Chronic atrial fibrillation

7. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids

  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: NCT01818375

Contacts
Contact: Gabriele Baldini, MD, MSc 5149341934 ext 25077 gabriele.baldini@mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Gabriele Baldini, MD    5149341934 ext 25077    gabriele.baldini@mcgill.ca   
Principal Investigator: Gabriele Baldini, MD, Msc         
Sponsors and Collaborators
Gabriele Baldini, MD, MSc, Assistant Professor
  More Information

Additional Information:
Publications:

Responsible Party: Gabriele Baldini, MD, MSc, Assistant Professor, MD, MSc, Anesthesiologist, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01818375     History of Changes
Other Study ID Numbers: 12-277-SDR
Study First Received: March 21, 2013
Last Updated: March 24, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Obstruction
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014