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Lipid Infusion Following Major Surgery

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ClinicalTrials.gov Identifier: NCT02463812
Recruitment Status : Unknown
Verified October 2016 by University of Alberta.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE April 21, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • Change in blood pressure at discharge from PACU [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
    Overall primary outcome will be collective vital signs
  • Change in respiration rate at discharge from PACU [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
    Overall primary outcome will be collective vital signs
  • Change in pulse at discharge from PACU [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
    Overall primary outcome will be collective vital signs
  • Change in oxygen saturation at discharge from PACU [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
    Overall primary outcome will be collective vital signs
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02463812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • Total volume of fluid required in recovery room [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
  • Total dosage of vasopressor required in recovery room [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
  • Length of stay in recovery room [ Time Frame: Upon discharge from PACU (expected average 2 hrs post-surgery) ]
  • Length of stay in hospital [ Time Frame: Upon discharge from hospital (expected 4-5 days post-surgery) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipid Infusion Following Major Surgery
Official Title  ICMJE Energy Supplement With Lipid Emulsion Following Major Surgery
Brief Summary Surgery puts a lot of stress on the body, and during recovery from surgery, the body uses a lot of energy to help with healing and getting stronger. Often, sugars are given before surgery to help give the body an energy boost. Lipid solutions can also be used as an energy source and are commonly used as supplements in patients needing long-term nutrition from an intravenous route (e.g., total parenteral nutrition) when they can not eat by mouth for a medical reason. Intralipid, a solution of lipid molecules from soybeans and eggs, is commonly used for patients who need nutrition and energy supplements. The investigators wish to test whether giving Intralipid immediately after surgery can improve recovery from major surgery.
Detailed Description

BACKGROUND The perioperative events associated with major surgery trigger the body's stress response, compromising optimal post-surgical recovery and outcomes. Moreover, traditional perioperative indications, such as restricting food up to two days before surgery, have been shown to be associated with poor outcomes following surgery. The Enhanced Recovery After Surgery (ERAS) protocol, initiated in the early 2000's, aimed to address these problems. The ERAS protocol has recommendations for pre-, intra-, and post-operative stages, with the goal of modifying physiological and psychological responses to surgery. A key component of ERAS is perioperative nutrition, including avoidance of fasting before surgery and carbohydrate loading up to two hours pre-surgery. It is hypothesized that adequate nutrition and provision of an energy source in the perioperative period can attenuate the body's stress response during surgery, thereby enabling faster and more successful recovery.

Early post-operative feeding is another recommendation of ERAS and is also intended to ensure optimal metabolic balance. Post-operative nutrition of ERAS patients generally involves oral feeding with energy-dense nutritional supplements in the days after surgery until the patient is ready for normal food intake. Lipids and carbohydrates form the bulk of these supplements, providing a readily available energy source. Lipid emulsions, such as Intralipid®, are used commonly in total parenteral nutrition and are also indicated as an energy source in patients for whom the usual intravenous fluid therapy would not be adequate. Lipid emulsions alone may therefore be helpful in enhancing recovery following major surgery, particularly in patients who are not good candidates for a strict ERAS protocol. With respect to short-term outcomes following surgery, Intralipid has been shown to modulate blood pressure by increasing systemic vascular resistance and cardiac output.

Only one study so far has evaluated post-surgery recovery outcomes following administration of lipid emulsion exclusively. The investigators found that patients receiving an intravenous infusion of lipid emulsion experienced better overall recovery and faster time eye opening and exit from the operating room compared to patients receiving an infusion of 0.9% normal saline. While these results suggest that post-operative lipid delivery improves recovery, the study did not assess differences in basic vital signs between the two groups, and the subjects were limited to those undergoing laparoscopic cholecystectomy. In this study, the investigators will recruit patients undergoing any surgery of the abdomen and assess post-operative outcomes, including vital signs, following an intravenous bolus of Intralipid® 20% or 0.9% normal saline.

OBJECTIVE To demonstrate that patients receiving an intravenous bolus of Intralipid® 20% immediately following surgery experience improved post-surgical recovery compared to patients receiving an intravenous saline bolus.

HYPOTHESIS The investigators hypothesize that patients who receive an intravenous bolus of Intralipid® following major abdominal surgery will show more stable vital signs and faster discharge from the recovery room compared to patients receiving a saline bolus.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Parenteral Nutrition
Intervention  ICMJE
  • Drug: Intralipid
  • Drug: Saline
Study Arms  ICMJE
  • Experimental: Intralipid
    Patients will receive Intralipid infusion in the recovery room.
    Intervention: Drug: Intralipid
  • Placebo Comparator: Control
    Patients will receive infusion of normal saline in the recovery room.
    Intervention: Drug: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (>18 years old)
  • Scheduled for abdominal surgery
  • Provide written, informed consent

Exclusion Criteria:

  • Patient refusal
  • Pre-existing neurological deficit
  • Existing or potential for coagulation abnormality
  • Local or systemic infection
  • Allergy to local anesthetic
  • Contraindication to propofol
  • Liver disease/compromised liver metabolism
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02463812
Other Study ID Numbers  ICMJE Pro00055553
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alberta
Verification Date October 2016

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