Goal Directed Fluid Therapy and Postoperative Ileus

NCT01818375 | Completed

• 1 other identifier: 12-277-SDR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (13)

• Intraoperative hemodynamic measurements

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

• Intraoperative and postoperative fluids and blood products required

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

• Vasoactive agents required

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

• Urinary output

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

• Intraoperative and postoperative urinary output

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

Study Arms (2)

Goal Directed Fluid Therapy (GDFT)

EXPERIMENTAL

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

Standard Fluid Therapy

ACTIVE COMPARATOR

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

Interventions

Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided PROCEDURE

Also known as: Esophageal doppler-Deltex Medical

Goal Directed Fluid Therapy (GDFT)

Standard fluid therapy OTHER

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

Standard Fluid Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• \. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids

Sponsors & Collaborators

• Gabriele Baldini, MD, MSc, Assistant Professor: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (6)

• Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.

  PMID: 12357146 BACKGROUND

• Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.

  PMID: 19837807 BACKGROUND

• Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26.

  PMID: 21873370 BACKGROUND

• Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.

  PMID: 23099039 BACKGROUND

• Rahbari NN, Zimmermann JB, Schmidt T, Koch M, Weigand MA, Weitz J. Meta-analysis of standard, restrictive and supplemental fluid administration in colorectal surgery. Br J Surg. 2009 Apr;96(4):331-41. doi: 10.1002/bjs.6552.

  PMID: 19283742 BACKGROUND

• Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.

  PMID: 23062720 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc, Anesthesiologist, Assistant Professor

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

CA (1)