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Clinical Trials/EUCTR2018-003899-13-NL
EUCTR2018-003899-13-NL
Active, not recruiting
Phase 1

The effect of IntraDialytic Parenteral Nutrition on nutritional status and quality of life in hemodialysis patients - IDPN-Study

Not provided0 sites206 target enrollmentNovember 19, 2018
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ConditionsMalnutrition / Sarcopenia (loss of muscle mass) in hemodialyse patients.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsOlimel N9

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Malnutrition / Sarcopenia (loss of muscle mass) in hemodialyse patients.
Sponsor
Not provided
Enrollment
206
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 19, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Not provided

Eligibility Criteria

Inclusion Criteria

  • •Age: \= 18 years
  • •Hemodialysis, 3 times / week, minimum 3,5 hours / session.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 80
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 126

Exclusion Criteria

  • •Life expectancy \< 6 months
  • •Planned kidney transplant within 4 months
  • •Active treatment for infection
  • •Parenteral nutrition for at least four weeks prior to screening
  • •Unipolar pacemaker with a very low sensitivity threshold
  • •Regular exclusion criteria for the use of parenteral nutrition in hemodialysis patients:
  • •Severe overhydration leading to respiratory insufficiency.
  • •Hypersensitivity for any ingredient or excipients
  • •Severe hepatic insufficiency, total bilirubin \> 20 µmol/l, ASAT \+ ALAT: \> 3 times higher
  • •than reference values.

Outcomes

Primary Outcomes

Not specified

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