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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

March 21, 2013
March 24, 2014
February 2013
April 2014   (final data collection date for primary outcome measure)
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.

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. Presence of nausea/vomiting OR abdominal distension AND ii. Absence of passing gas, OR stool or not tolerating oral diet.

Complete list of historical versions of study NCT01818375 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Goal Directed Fluid Therapy and Postoperative Ileus
Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Postoperative Ileus
  • Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided
    Other Name: Esophageal doppler-Deltex Medical
  • Other: Standard fluid therapy
    Other Name: Intravenous infusion as recommended by international guidelines and anesthesia text-books
  • 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.
    Intervention: Procedure: Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided
  • 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
    Intervention: Other: Standard fluid therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
April 2014
April 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Gabriele Baldini, MD, MSc 5149341934 ext 25077 gabriele.baldini@mcgill.ca
Canada
 
NCT01818375
12-277-SDR
No
Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Center
Gabriele Baldini, MD, MSc, Assistant Professor
Not Provided
Not Provided
McGill University Health Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP