Goal Directed Fluid Therapy and Postoperative Ileus

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided

Standard fluid therapy

About this trial

This is an interventional prevention trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Sites / Locations

Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Goal Directed Fluid Therapy (GDFT)

Standard Fluid Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Primary postoperative ileus (POI)

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

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

Vasoactive agents required

Urinary output

Intraoperative and postoperative urinary output

Intraoperative and Postoperative opioid consumption

Intraoperative opioid administration and postoperative opioid consumption

Postoperative nausea and vomiting (PONV)

Time spent out of bed

Postoperative complications (Clavien Classification)

Patients' weight

Quality of surgical recovery score

Readiness to be discharged

: 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

Full Information

NCT ID

NCT01818375

First Posted

March 21, 2013

Last Updated

October 1, 2015

Sponsor

Gabriele Baldini, MD, MSc, Assistant Professor

1. Study Identification

Unique Protocol Identification Number

NCT01818375

Brief Title

Goal Directed Fluid Therapy and Postoperative Ileus

Official Title

Goal-directed Fluid Therapy and Postoperative Ileus After Elective Laparoscopic Colorectal Surgery Using an Enhanced Recovery Program: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gabriele Baldini, MD, MSc, Assistant Professor

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Ileus

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Goal Directed Fluid Therapy (GDFT)

Arm Type

Experimental

Arm Description

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

Arm Title

Standard Fluid Therapy

Arm Type

Active Comparator

Arm Description

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 Type

Procedure

Intervention Name(s)

Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided

Other Intervention Name(s)

Esophageal doppler-Deltex Medical

Intervention Type

Other

Intervention Name(s)

Standard fluid therapy

Other Intervention Name(s)

Intravenous infusion as recommended by international guidelines and anesthesia text-books

Primary Outcome Measure Information:

Title

Primary postoperative ileus (POI)

Description

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.

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measure Information:

Title

Intraoperative hemodynamic measurements

Description

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)

Time Frame