Postoperative Protein CatabolismNCT01414946
The Effect of Intravenous Nutrition in Patients Undergoing Abdominal Surgery
A study testing Intravenous nutrition with glucose and amino acids and Intravenous nutrition with amino acids in people with Postoperative Protein Catabolism, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Loss of muscle protein and mass are the main causes of fatigue after bowel surgery which may result in a longer hospital stay and a higher rate of complications. This problem is especially important for patients after surgery for bowel cancer because cancer itself causes a waste of muscle protein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Protein Catabolism
- What is being tested?
- Intravenous nutrition with glucose and amino acids and Intravenous nutrition with amino acids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Jul 2011
- 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
- American Society of Anesthesiologists <3
- colorectal surgery for non-metastatic colorectal carcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy, sigmoid resection
- ability to give informed consent
Who cannot join
- signs of severe malnutrition or obesity: body mass index <18 or >25 >10% involuntary body weight loss over the preceding 6 months serum albumin <21 g/L
- significant cardiorespiratory, hepatic, renal and neurological disease
- ingestion of drugs known to affect protein, glucose and lipid metabolism (for example steroids)
- musculoskeletal or neuromuscular disease
- severe anemia (hemoglobin <10 g/dL)
- pregnancy
- history of severe sciatica or back surgery or other conditions which
- contraindicate the use of epidural catheters
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Victoria Hospital, McGill University Health Centre
Montreal, Quebec, H3A 1A1
About this study
Official title: THE PROTEIN SPARING EFFECT OF PERIOPERATIVE NUTRITION: How Important is the Patient's Catabolic State Before Surgery and do we Need Glucose?
Loss of muscle protein and mass are the main causes of fatigue after bowel surgery which may result in a longer hospital stay and a higher rate of complications. This problem is especially important for patients after surgery for bowel cancer because cancer itself causes a waste of muscle protein. Anesthesiologists can decrease these negative effects of surgery by choosing the type of pain treatment (analgesia) and by giving nutrition (sugar and protein). Our group recently observed that optimal pain relief with epidural catheters (these are placed in the so called epidural space, which lies between the spine and the skin of the back) in combination with a low calorie protein diet intravenously (through the vein) maintains the body's protein stores after bowel surgery.
The goal of our new research program is to find out whether this protein saving effect depends on how protein depleted the patient is before surgery. In other words we would like to answer the question: do cancer patients who show protein wasting before the operation benefit more from feeding than patients who show no signs of protein wasting? A second goal of this program is to find out if we need to use sugar as part of the diet or whether the infusion of protein alone is sufficient. Just giving protein would make feeding not only easier but also would avoid the increase in the patient's own blood sugar during and after the operation, which typically occurs when sugar is given intravenously during that period.
Read the detailed description
- Goals The overall goal of perioperative nutrition support is to abolish protein wasting and to promote anabolic processes by directing amino acids into protein synthesis rather than oxidation. Protein repletion and enhancement of anabolism appear to be particularly important in cancer patients who enter major abdominal surgery in a catabolic state.
- Objectives The objectives of this research program are
- to examine whether the anabolic effects of hypocaloric nutrition depend on the degree of catabolism before the operation and thus identify patients who benefit the most from perioperative nutrition support (study I)
- to investigate whether excluding glucose from hypocaloric nutrition, i.e. infusing an isonitrogenous amount of amino acids without glucose avoids hyperglycemia and, thus, accentuates the patient's anabolic response to feeding (study II).
In order to confirm the validity of our assumptions we will perform two consecutive studies in two distinct patient populations. For the assessment of the patients' catabolic state and obtaining insight into the biochemical mechanisms, whereby the effects of nutrition are mediated, stable isotope tracer kinetics will be applied. Using primed continuous infusions of L-[1-13C]leucine and [6,6-2H2]glucose we will quantitate the whole body dynamics of protein and glucose metabolism, i.e. protein breakdown, amino acid oxidation, protein synthesis, glucose production and glucose uptake before and after surgery. A positive protein balance (difference between protein synthesis and protein breakdown) will be used as an indicator of anabolism. Anabolic processes at the organ level (liver, muscle), i.e. fractional synthesis rates of the acute phase proteins albumin and fibrinogen and muscle protein synthesis will be determined using L-[2H5]phenylalanine infusions. Skeletal muscle protein catabolism will be characterized by measuring the mRNA expression of ubiquitin and two of its key ligases in muscle (MAFbx/atrogen-1 and MuRF-1).
- Conditions
- Postoperative Protein Catabolism
- Being tested
- Intravenous nutrition with glucose and amino acids, Intravenous nutrition with amino acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous nutrition with glucose and amino acidsOther
Glucose and amino acids intravenously starting 20 hours before the operation until the second postoperative day. Glucose provides 50% and amino acids 20% of each patient's measured resting energy expenditure.
Intravenous nutrition with amino acidsOther
Amino acids intravenously starting 20 hours before the operation until the second postoperative day. Amino acids providing 20% of each patient's measured resting energy expenditure.
| Study group | Role | What they receive |
|---|---|---|
| Glucose and amino acids | Experimental | Perioperative nutrition with glucose and amino acids Receives: Other: Intravenous nutrition with glucose and amino acids |
| Amino acids only | Active comparator | Perioperative nutrition with amino acids only Receives: Other: Intravenous nutrition with amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein balance
Measured: two days after surgery
Secondary outcomes (4)
albumin synthesis
Measured: two days after surgery
fibrinogen synthesis
Measured: two days after surgery
total plasma protein synthesis
Measured: two days after surgery
mRNA expression of ubiquitin
Measured: two days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Protein CatabolismStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Schricker, MD PhD, Principal investigator, Department of Anaesthesia, McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414946
- Sponsor's protocol ID
- CIHR-2011
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Schricker T, Wykes L, Meterissian S, Hatzakorzian R, Eberhart L, Carvalho G, Meguerditchian A, Nitschmann E, Lattermann R. The anabolic effect of perioperative nutrition depends on the patient's catabolic state before surgery. Ann Surg. 2013 Jan;257(1):155-9. doi: 10.1097/SLA.0b013e31825ffc1f.
PubMed 22878551
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE PROTEIN SPARING EFFECT OF PERIOPERATIVE NUTRITION: How Important is the Patient's Catabolic State Before Surgery and do we Need Glucose?
- ClinicalTrials.gov ID
- NCT01414946
- Acronym / sponsor ID
- CIHR-2011
- Conditions
- Postoperative Protein Catabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Aug 2011 (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.
Loss of muscle protein and mass are the main causes of fatigue after bowel surgery which may result in a longer hospital stay and a higher rate of complications. This problem is especially important for patients after surgery for bowel cancer because cancer itself causes a waste of muscle protein. Anesthesiologists can decrease these negative effects of surgery by choosing the type of pain treatment (analgesia) and by giving nutrition (sugar and protein). Our group recently observed that optimal pain relief with epidural catheters (these are placed in the so called epidural space, which lies between the spine and the skin of the back) in combination with a low calorie protein diet intravenously (through the vein) maintains the body's protein stores after bowel surgery.
The goal of our new research program is to find out whether this protein saving effect depends on how protein depleted the patient is before surgery. In other words we would like to answer the question: do cancer patients who show protein wasting before the operation benefit more from feeding than patients who show no signs of protein wasting? A second goal of this program is to find out if we need to use sugar as part of the diet or whether the infusion of protein alone is sufficient. Just giving protein would make feeding not only easier but also would avoid the increase in the patient's own blood sugar during and after the operation, which typically occurs when sugar is given intravenously during that period.
Detailed description
- Goals The overall goal of perioperative nutrition support is to abolish protein wasting and to promote anabolic processes by directing amino acids into protein synthesis rather than oxidation. Protein repletion and enhancement of anabolism appear to be particularly important in cancer patients who enter major abdominal surgery in a catabolic state.
- Objectives The objectives of this research program are
- to examine whether the anabolic effects of hypocaloric nutrition depend on the degree of catabolism before the operation and thus identify patients who benefit the most from perioperative nutrition support (study I)
- to investigate whether excluding glucose from hypocaloric nutrition, i.e. infusing an isonitrogenous amount of amino acids without glucose avoids hyperglycemia and, thus, accentuates the patient's anabolic response to feeding (study II).
In order to confirm the validity of our assumptions we will perform two consecutive studies in two distinct patient populations. For the assessment of the patients' catabolic state and obtaining insight into the biochemical mechanisms, whereby the effects of nutrition are mediated, stable isotope tracer kinetics will be applied. Using primed continuous infusions of L-[1-13C]leucine and [6,6-2H2]glucose we will quantitate the whole body dynamics of protein and glucose metabolism, i.e. protein breakdown, amino acid oxidation, protein synthesis, glucose production and glucose uptake before and after surgery. A positive protein balance (difference between protein synthesis and protein breakdown) will be used as an indicator of anabolism. Anabolic processes at the organ level (liver, muscle), i.e. fractional synthesis rates of the acute phase proteins albumin and fibrinogen and muscle protein synthesis will be determined using L-[2H5]phenylalanine infusions. Skeletal muscle protein catabolism will be characterized by measuring the mRNA expression of ubiquitin and two of its key ligases in muscle (MAFbx/atrogen-1 and MuRF-1).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose and amino acids | Experimental | Other: Intravenous nutrition with glucose and amino acidsPerioperative nutrition with glucose and amino acids |
| Amino acids only | Active comparator | Other: Intravenous nutrition with amino acidsPerioperative nutrition with amino acids only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists <3
- colorectal surgery for non-metastatic colorectal carcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy, sigmoid resection
- ability to give informed consent
Key exclusion criteria (8 listed)
- signs of severe malnutrition or obesity: body mass index <18 or >25 >10% involuntary body weight loss over the preceding 6 months serum albumin <21 g/L
- significant cardiorespiratory, hepatic, renal and neurological disease
- ingestion of drugs known to affect protein, glucose and lipid metabolism (for example steroids)
- musculoskeletal or neuromuscular disease
- severe anemia (hemoglobin <10 g/dL)
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 |
|---|---|---|
| Intravenous nutrition with glucose and amino acidsGlucose and amino acids intravenously starting 20 hours before the operation until the second postoperative day. Glucose provides 50% and amino acids 20% of each patient's measured resting energy expenditure. | Other | Glucose and amino acids |
| Intravenous nutrition with amino acidsAmino acids intravenously starting 20 hours before the operation until the second postoperative day. Amino acids providing 20% of each patient's measured resting energy expenditure. | Other | Amino acids only |
Primary outcome
protein balance
Time frame: two days after surgery
4 secondary outcomes
albumin synthesis
Time frame: two days after surgery
fibrinogen synthesis
Time frame: two days after surgery
total plasma protein synthesis
Time frame: two days after surgery
mRNA expression of ubiquitin
Time frame: two days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Derived from this study: PubMed 22878551Schricker T, Wykes L, Meterissian S, Hatzakorzian R, Eberhart L, Carvalho G, Meguerditchian A, Nitschmann E, Lattermann R. The anabolic effect of perioperative nutrition depends on the patient's catabolic state before surgery. Ann Surg. 2013 Jan;257(1):155-9. doi: 10.1097/SLA.0b013e31825ffc1f.
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.
Thomas Schricker, MD PhD principal investigator
Department of Anaesthesia, McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous nutrition with glucose and amino acids and Intravenous nutrition with amino acids in people with Postoperative Protein Catabolism, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 8 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: finished, as of the sponsor's last update on 11 Aug 2011. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
protein balance (time frame: two days after surgery). 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 NCT01414946, which also lists 1 linked publication.
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 11 Aug 2011.