Amino acid–only IDPN for adults on dialysis with malnutrition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This retrospective observational analysis uses existing medical records from Bangli Medika Canti Hospital in Indonesia to compare adults on maintenance hemodialysis who received 7.2% amino acid IDPN (KIDMIN) for at least 3 months with those who did not receive IDPN. It focuses on adults with malnutrition and anemia, evaluating associations with nutritional markers and clinical outcomes. No treatments are assigned by the researchers, and data are analyzed as part of routine care from July 2023 to December 2024. The study addresses real-world use of amino acid–only IDPN and its potential link to improved nutritional status in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Outpatients undergoing maintenance hemodialysis at Bangli Medika Canti Hospital who are clinically stable and are not experiencing any acute condition.
3. Confirmed malnutrition, defined as a condition resulting from insufficient or imbalanced intake of energy, protein, and/or other nutrients, which may adversely affect body composition, physical and mental function, and clinical outcomes, and meeting all of the following criteria within 1-7 days:

   * Body Mass Index (BMI) less than 18.5 kg/m2
   * Mid-upper arm circumference (MUAC) less than 24.5 cm
   * Serum pre-albumin level less than 16 mg/dL
4. Confirmed anemia, defined as a hemoglobin (Hb) concentration below the normal reference range within 1-7 days, specifically an Hb level of less than 13.0 g/dL in male patients or less than 12.0 g/dL in female patients.
5. At least 3 months of maintenance haemodialysis with duration of 3-4 hours per session, 2-3 times per week.
6. Provision of written informed consent prior to enrollment in this study (patient is available, can be contacted and approached).

Exclusion Criteria:

1. Patients who are hospitalized at the time of data collection or who require hospitalization during the observation period.
2. History of acute bleeding at the time of admission or requiring blood transfusion.
3. Patients with clinically evident edema or fluid overload.
4. Patients receiving other enteral or parenteral nutritional support concomitantly during observation period.
5. Patients who had received IDPN before observation period
6. Patients who have received IDPN in other dialysis clinic/facilities before transferring to Bangli Medika Canti Hospital will be excluded from the study.
7. Patients for whom the data required to evaluate the primary endpoint are unavailable.
8. Patients with duplicate enrollment in the same study protocol.
9. Patients who receive albumin administration during study period.

Where it's running

• Bangli Medika Canti Hospital
  Bangli, Bali, Indonesia Recruiting

Study contacts

• Study coordinator: Dini Arini, MD
• Email: dadea441@gmail.com
• Phone: 62217654466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.