NCT00501956

Brief Summary

Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy. In cases where primary treatment of malnutrition is not effective, intradialytic parenteral nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids, carbohydrates and fatty acids as well as vitamins and trace elements can be given to the patients. Effectiveness of IDPN has to be verified.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

6.4 years

First QC Date

July 16, 2007

Last Update Submit

March 1, 2016

Conditions

MalnutritionComplication of Hemodialysis

Keywords

chronic renal replacement therapymalnutrition anorexiaparenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Change in prealbumin levels

    8 weeks

Secondary Outcomes (1)

  • Serum albumin, transferrin, nutritional status

    8 weeks

Study Arms (2)

Intradialytic parenteral nutrition

EXPERIMENTAL

Individually compounded intradialytic parenteral nutrition (IDPN) including glucose, amino acids, lipids, L-Carnitine, trace elements and water-soluable vitamins 3x / week over 16 weeks + 12 weeks postinterventional observation.

Drug: Intradialytic Parenteral Nutrition (IDPN)

Control Group

NO INTERVENTION

Observation over 28 weeks (16 + 12 weeks).

Interventions

Intradialytic Parenteral Nutrition (IDPN)DRUG

compounded IDPN, 3 x/week, 16 weeks intervention

Also known as: Individually compounded parenteral nutrition
Intradialytic parenteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemodialysis therapy more than 6 months
  • three times per week hemodialysis
  • albumin \< 35 g/l
  • prealbumin \< 250 mg/l
  • phase angle \< 4,5°
  • SGA score grade B or C
  • informed consent

You may not qualify if:

  • inadequate dialysis (Kt/V \< 1,2)
  • chemotherapy or radiotherapy
  • cardiac pacemaker
  • acute bacterial infection
  • acute immunological disease
  • cancer disease
  • severe hepatic insufficiency
  • interferon therapy
  • HIV disease
  • severe diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interneph e.V. Institute for Applied Nephrology

Aachen, 52074, Germany

Location

Related Publications (2)

  • Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. doi: 10.1172/JCI16494. No abstract available.

    PMID: 12189236BACKGROUND

  • Marsen TA, Beer J, Mann H; German IDPN-Trial group. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017 Feb;36(1):107-117. doi: 10.1016/j.clnu.2015.11.016. Epub 2015 Dec 12.

    PMID: 26708726DERIVED

MeSH Terms

Conditions

MalnutritionHyperphagia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Helmut Mann, Prof. Dr.

    Interneph e.V, Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

July 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 3, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)