Intradialytic Parenteral Nutrition in Hemodialysis Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

25% of hemodialysis patients who are treated for more than 5 years suffer from protein malnutrition. 7% have a protein catabolic rate less than 0,6 g/kgBW and day.

The conventional treatment of malnutrition include dietetic counseling, psychologic advice and giving additional oral nutrients.In many cases this kind of therapy is uneffective. If supplementary enteral nutrition is used, the additional intake of water has to be taken into consideration.

IDPN is a mode of treatment by which disadvantages of enteral nutrition and fluid overload of the patients can be avoided.During each dialysis session nutrients can be given and additional water simultaneously can be removed by ultrafiltration.

Some publications have shown that the catabolic state of the patients can be converted into an anabolic state. There are only small randomized studies showing the positive effect of IDPN.

In this german multicenter study malnourished hemodialysis patients are randomized into two groups. One group is treated with IDPN during each dialysis session for 16 weeks followed by 12 weeks of follow-up without IDPN. The control-group does not receive IDPN.

The parameters of metabolism are: Albumin, prealbumin, transferrin, phase angle alpha (bioimpedance), proteincatabolic rate (formal urea kinetics), BMI and subjective global assessment (SGA score). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00501956
Study type	Interventional
Source	Fresenius Kabi
Contact
Status	Completed
Phase	Phase 4
Start date	July 2004
Completion date	December 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed	`NCT03268902` - Early Life Interventions for Childhood Growth and Development In Tanzania	Phase 2/Phase 3
Active, not recruiting	`NCT04746664` - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia	N/A
Completed	`NCT04608656` - Livestock for Health Project	N/A
Completed	`NCT06009198` - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan	N/A
Recruiting	`NCT05417672` - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting	`NCT05257980` - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial	N/A
Completed	`NCT05015647` - Low Protein Diet in CKD Patients at Risk of Malnutrition	N/A
Completed	`NCT03628196` - A Nutrition-Focused QIP in Outpatient Clinics
Enrolling by invitation	`NCT04675229` - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting	`NCT04627376` - Multimodal Program for Cancer Related Cachexia Prevention	N/A
Not yet recruiting	`NCT06047054` - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting	`NCT05860556` - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting	`NCT04398836` - Preoperative Nutrition for Crohn's Disease Patients	Phase 3
Not yet recruiting	`NCT04183075` - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture	N/A
Not yet recruiting	`NCT03150927` - Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children	N/A
Recruiting	`NCT03408067` - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients	N/A
Recruiting	`NCT02833740` - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition	N/A
Completed	`NCT02938247` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake	N/A
Completed	`NCT02938234` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intradialytic Parenteral Nutrition in Hemodialysis Patients — IDPNHD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms