Parenteral NutritionNCT02463812
Lipid Infusion Following Major Surgery
A study testing Intralipid and Saline in people with Parenteral Nutrition, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- Intralipid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years old)
- Scheduled for abdominal surgery
- Provide written, informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Energy Supplement With Lipid Emulsion Following Major Surgery
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.
Read the 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.
- Conditions
- Parenteral Nutrition
- Being tested
- Intralipid, Saline
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntralipidDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Intralipid | Experimental | Patients will receive Intralipid infusion in the recovery room. Receives: Drug: Intralipid |
| Control | Placebo comparator | Patients will receive infusion of normal saline in the recovery room. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure at discharge from PACU
Overall primary outcome will be collective vital signs
Measured: 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
Measured: During stay in recovery room (expected average 2 hrs)
Change in pulse at discharge from PACU
Overall primary outcome will be collective vital signs
Measured: 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
Measured: During stay in recovery room (expected average 2 hrs)
Secondary outcomes (4)
Total volume of fluid required in recovery room
Measured: During stay in recovery room (expected average 2 hrs)
Total dosage of vasopressor required in recovery room
Measured: During stay in recovery room (expected average 2 hrs)
Length of stay in recovery room
Measured: Upon discharge from PACU (expected average 2 hrs post-surgery)
Length of stay in hospital
Measured: Upon discharge from hospital (expected 4-5 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463812
- Sponsor's protocol ID
- Pro00055553
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2015
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24612915Soop 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.
PubMed 15449264Varadhan 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.
PubMed 20643305
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Supplement With Lipid Emulsion Following Major Surgery
- ClinicalTrials.gov ID
- NCT02463812
- Acronym / sponsor ID
- Pro00055553
- Conditions
- Parenteral Nutrition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralipid | Experimental | Drug: IntralipidPatients will receive Intralipid infusion in the recovery room. |
| Control | Placebo comparator | Drug: SalinePatients will receive infusion of normal saline in the recovery room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (>18 years old)
- Scheduled for abdominal surgery
- Provide written, informed consent
Key exclusion criteria (7 listed)
- Patient refusal
- Pre-existing neurological deficit
- Existing or potential for coagulation abnormality
- Local or systemic infection
- Allergy to local anesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralipid | Drug | Intralipid |
| Saline | Drug | Control |
Primary outcome
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
4 secondary outcomes
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 24612915Li 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.
- Background: PubMed 15449264Soop 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.
- Background: PubMed 20643305Varadhan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralipid and Saline in people with Parenteral Nutrition, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure at discharge from PACU (time frame: During stay in recovery room (expected average 2 hrs)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463812, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.