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AzTrials

UndernutritionPhase 4NCT00559520

The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

A Phase 4 study testing Impact and Oral Impact in people with Undernutrition, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The role of preoperative oral immunonutrition in major vascular surgery. The mean purpose of this study was to determine the prevalence of post-operative infection complications after major vascular surgery in group of patients with preoperative oral immunonutrition. This group was compared to a control group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Undernutrition
What is being tested?
Impact and Oral Impact
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteFrance
Study dates
Feb 2002to Dec 2011
Phase
Phase 4
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

  • Intervention planned since at least 5 days before surgery
  • Duration of hospitalization of at least 5 days

Who cannot join

  • Pregnant or lactating woman
  • Patient with severe renal insufficiency
  • Patient under 18 years old
  • Patient infected with HIV,hépatitis B or C

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de NICE, Department of Vascular Surgery

    Nice, 06000

Other trials in France

About this study

The role of preoperative oral immunonutrition in major vascular surgery.

The mean purpose of this study was to determine the prevalence of post-operative infection complications after major vascular surgery in group of patients with preoperative oral immunonutrition.

This group was compared to a control group.

Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on postoperative mortality (30 days), the medium length of stay in the hospital and the cost of treatment in the two groups

Conditions
Undernutrition
Being tested
Impact, Oral Impact
Keywords
Patients, Suffering, Undernutrition, Requiring, Vascular, Surgery
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImpactDietary supplement

    Patient receiving 3 drinks "Impact" a day during 5 days before surgery

  • Oral ImpactDietary supplement

    Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

Study groups in NCT00559520
Study groupRoleWhat they receive
ImpactActive comparatorpatient receiving 3 drinks "Impact" a day during 5 days before surgery
Receives: Dietary Supplement: Impact
Oral ImpactExperimentalPatient receiving 3 drinks "Oral Impact" a day during 5 days before surgery
Receives: Dietary Supplement: Oral Impact

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Measured: before surgery, five days and thirty days after surgery

  2. Arisen of an infectious complication

    Measured: during the period of 30 days following the surgery

  3. Arisen of non infectious complication

    Measured: during the period of 30 days following the surgery

Secondary outcomes (3)

  1. Primary and secondary permeability

    Measured: at 5 and 30 days after surgery

  2. Pain

    Measured: at 5 and 30 days after surgery

  3. Healing

    Measured: at 5 and 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2007 (estimated)
  2. Study startFeb 2002
  3. Primary completionNov 2011
  4. Study completionDec 2011

Resources

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 4
Primary purpose
Screening
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559520
Sponsor's protocol ID
PHRC 2004
Status last verified
Dec 2011
First submitted
14 Nov 2007
Last updated
9 Dec 2011
Results posted
No
Data monitoring committee
No

Publications

  • Gallagher-Allred CR, Voss AC, Finn SC, McCamish MA. Malnutrition and clinical outcomes: the case for medical nutrition therapy. J Am Diet Assoc. 1996 Apr;96(4):361-6, 369; quiz 367-8. doi: 10.1016/s0002-8223(96)00099-5.

    PubMed 8598437

  • Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.

    PubMed 12122555

  • Hill GL, Blackett RL, Pickford I, Burkinshaw L, Young GA, Warren JV, Schorah CJ, Morgan DB. Malnutrition in surgical patients. An unrecognised problem. Lancet. 1977 Mar 26;1(8013):689-92. doi: 10.1016/s0140-6736(77)92127-4.

    PubMed 66485

  • Arora NS, Rochester DF. Respiratory muscle strength and maximal voluntary ventilation in undernourished patients. Am Rev Respir Dis. 1982 Jul;126(1):5-8. doi: 10.1164/arrd.1982.126.1.5.

    PubMed 7091909

  • Heymsfield SB, Bethel RA, Ansley JD, Gibbs DM, Felner JM, Nutter DO. Cardiac abnormalities in cachectic patients before and during nutritional repletion. Am Heart J. 1978 May;95(5):584-94. doi: 10.1016/0002-8703(78)90300-9. No abstract available.

    PubMed 416704

  • Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6. doi: 10.1177/0148607188012004371.

    PubMed 3138447

  • Gianotti L, Braga M, Nespoli L, Radaelli G, Beneduce A, Di Carlo V. A randomized controlled trial of preoperative oral supplementation with a specialized diet in patients with gastrointestinal cancer. Gastroenterology. 2002 Jun;122(7):1763-70. doi: 10.1053/gast.2002.33587.

    PubMed 12055582

  • Gianotti L, Braga M, Frei A, Greiner R, Di Carlo V. Health care resources consumed to treat postoperative infections: cost saving by perioperative immunonutrition. Shock. 2000 Sep;14(3):325-30. doi: 10.1097/00024382-200014030-00015.

    PubMed 11028551

  • Robinson G, Goldstein M, Levine GM. Impact of nutritional status on DRG length of stay. JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):49-51. doi: 10.1177/014860718701100149.

    PubMed 3102782

  • Chima CS, Barco K, Dewitt ML, Maeda M, Teran JC, Mullen KD. Relationship of nutritional status to length of stay, hospital costs, and discharge status of patients hospitalized in the medicine service. J Am Diet Assoc. 1997 Sep;97(9):975-8; quiz 979-80. doi: 10.1016/S0002-8223(97)00235-6.

    PubMed 9284874

  • Braunschweig C, Gomez S, Sheean PM. Impact of declines in nutritional status on outcomes in adult patients hospitalized for more than 7 days. J Am Diet Assoc. 2000 Nov;100(11):1316-22; quiz 1323-4. doi: 10.1016/S0002-8223(00)00373-4.

    PubMed 11103653

  • Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta-analysis of controlled trials. BMJ. 2001 Oct 6;323(7316):773-6. doi: 10.1136/bmj.323.7316.773.

    PubMed 11588077

  • Spark JI, Robinson JM, Gallavin L, Gough MJ, Homer-Vanniasinkam S, Kester RC, Scott DJ. Patients with chronic critical limb ischaemia have reduced total antioxidant capacity and impaired nutritional status. Eur J Vasc Endovasc Surg. 2002 Dec;24(6):535-9. doi: 10.1053/ejvs.2002.1755.

    PubMed 12443751

  • Evoy D, Lieberman MD, Fahey TJ 3rd, Daly JM. Immunonutrition: the role of arginine. Nutrition. 1998 Jul-Aug;14(7-8):611-7. doi: 10.1016/s0899-9007(98)00005-7.

    PubMed 9684265

  • Kirk SJ, Barbul A. Role of arginine in trauma, sepsis, and immunity. JPEN J Parenter Enteral Nutr. 1990 Sep-Oct;14(5 Suppl):226S-229S. doi: 10.1177/014860719001400514. No abstract available.

    PubMed 2232107

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Impact and Oral Impact in people with Undernutrition, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

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 2 inclusion and 4 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 9 Dec 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 France. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Weight (time frame: before surgery, five days and thirty days after surgery). The study lists 3 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 NCT00559520, which also lists 23 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 9 Dec 2011.

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