Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314834

Enrollment

204

Registered

2006-04-17

Start date

2001-01-31

Completion date

2004-12-31

Last updated

2006-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Malnutrition

Keywords

hemodialysis, intradialytic parenteral nutrition, oral supplementation, survival, hospitalization, serum albumin, prealbumin, transthyretin

Brief summary

Detailed description

IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score. Patient eligibility: adult patients ≤ 82 y with HD vintage \> 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L. Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period. Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.

Interventions

DRUGIntradialytic parenteral nutrition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 82 Years

Healthy volunteers

Inclusion criteria

* age between 18 and 82 years * hemodialysis vintage more than 6 months * two of the following markers of malnutrition: * body mass index (BMI) \<= 20 kg/m2 * body weight loss within 6 months \>= 10 percent * serum albumin \<= 35 g/L * prealbumin \<= 300 mg/L

Exclusion criteria

* weekly dialysis time \< 12 h * urea Kt/V index \< 1.2 * serum albumin \> 38 g/L * prealbumin \> 330 mg/L * hypertriglyceridemia \> 2.5 mmol/L * associated comorbidities compromising the one-year survival * treatment by oral, enteral or parenteral feeding during the last 3 months * hospitalization at time of randomization

Design outcomes

Primary

Measure	Time frame
mortality	—

Secondary

Measure	Time frame
hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026