NCT02463812

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 25, 2020

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

April 21, 2015

Last Update Submit

March 23, 2020

Conditions

Parenteral Nutrition

Outcome Measures

Primary Outcomes (4)

  • Change in blood pressure at discharge from PACU

    Overall primary outcome will be collective vital signs

    During stay in recovery room (expected average 2 hrs)

  • Change in respiration rate at discharge from PACU

    Overall primary outcome will be collective vital signs

    During stay in recovery room (expected average 2 hrs)

  • Change in pulse at discharge from PACU

    Overall primary outcome will be collective vital signs

    During stay in recovery room (expected average 2 hrs)

  • Change in oxygen saturation at discharge from PACU

    Overall primary outcome will be collective vital signs

    During stay in recovery room (expected average 2 hrs)

Secondary Outcomes (4)

  • Total volume of fluid required in recovery room

    During stay in recovery room (expected average 2 hrs)

  • Total dosage of vasopressor required in recovery room

    During stay in recovery room (expected average 2 hrs)

  • Length of stay in recovery room

    Upon discharge from PACU (expected average 2 hrs post-surgery)

  • Length of stay in hospital

    Upon discharge from hospital (expected 4-5 days post-surgery)

Study Arms (2)

Intralipid

EXPERIMENTAL

Patients will receive Intralipid infusion in the recovery room.

Drug: Intralipid

Control

PLACEBO COMPARATOR

Patients will receive infusion of normal saline in the recovery room.

Drug: Saline

Interventions

IntralipidDRUG
Intralipid
SalineDRUG
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (3)

  • Li Q, Yang D, Liu J, Zhang H, Zhang J. Intravenous lipid emulsion improves recovery time and quality from isoflurane anaesthesia: a double-blind clinical trial. Basic Clin Pharmacol Toxicol. 2014 Aug;115(2):222-8. doi: 10.1111/bcpt.12223. Epub 2014 Mar 24.

    PMID: 24612915BACKGROUND

  • Soop M, Carlson GL, Hopkinson J, Clarke S, Thorell A, Nygren J, Ljungqvist O. Randomized clinical trial of the effects of immediate enteral nutrition on metabolic responses to major colorectal surgery in an enhanced recovery protocol. Br J Surg. 2004 Sep;91(9):1138-45. doi: 10.1002/bjs.4642.

    PMID: 15449264BACKGROUND

  • Varadhan KK, Lobo DN, Ljungqvist O. Enhanced recovery after surgery: the future of improving surgical care. Crit Care Clin. 2010 Jul;26(3):527-47, x. doi: 10.1016/j.ccc.2010.04.003.

    PMID: 20643305BACKGROUND

MeSH Terms

Conditions

Hyperphagia

Interventions

soybean oil, phospholipid emulsionSodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

June 4, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

March 25, 2020

Record last verified: 2016-10

Locations

CA(1)