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OpenTrials
Completed

NCT Number: NCT00179153

Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Kidney Foundation

Nashville, Tennessee, 37215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On CHD dialysis for more than 6 months
  • Adequately dialyzed (Kt/V > 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V > 1.0 but < 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study.
  • Suboptimal nutritional status identified by one of the following criteria:
  • Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months
  • Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight.
  • Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion:
  • Serum albumin less than 4.0 g/dl
  • Serum transferrin concentration less than 250 mg/dl
  • Serum prealbumin concentration less than 32 mg/dl
  • Subjective Global Assessment Score less than 5.

Exclusion criteria

  • Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available)
  • Refusal to sign a consent form
  • On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.

Treatment and study plan

Nepro nutritional supplement

Dietary Supplement

oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months

Primary outcomes

  1. increase in serum albumin

    Time frame: 6 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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