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Lipid Infusion Following Major Surgery

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

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.

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Drug: Intralipid Drug: Saline Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Energy Supplement With Lipid Emulsion Following Major Surgery
Study Start Date : May 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2017

Arm Intervention/treatment
Experimental: Intralipid
Patients will receive Intralipid infusion in the recovery room.
Drug: Intralipid
Placebo Comparator: Control
Patients will receive infusion of normal saline in the recovery room.
Drug: Saline



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Total volume of fluid required in recovery room [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
  2. Total dosage of vasopressor required in recovery room [ Time Frame: During stay in recovery room (expected average 2 hrs) ]
  3. Length of stay in recovery room [ Time Frame: Upon discharge from PACU (expected average 2 hrs post-surgery) ]
  4. Length of stay in hospital [ Time Frame: Upon discharge from hospital (expected 4-5 days post-surgery) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463812


Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta