Iatrogenic Deficiencies in ICU Patients With Prolonged Continuous Renal Replacement Therapy

NCT06983197 | Not Yet Recruiting

• 1 other identifier: 2024-07642-01
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

ICU patients are recruited after at least 5 days treatment with continuous renal replacement therapy. Blood samples are drawn at time of recruitment and then every 3-5 days until ceseation of renal replacement therapy. Samples will be analyzed for concentrations of trace elements, vitamins and amino acids. 10 adult ICU patients treated for two weeks without renal replacement therapy will be sampled at one time point to serve as controls.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Concentration of trace element

  Measurments of trace elements and vitamins as compared to established reference values as well as non-CRRT controls

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (2)

• Amino acids

  From enrollment to the end of treatment at 4 weeks

• Vitamins

  At all measuring points

Study Arms (2)

CRRT patients

Patients, all ages, that receive CRRT for at least five days.

Diagnostic Test: blood test

Non-CRRT patient

Adult patients, \>17 yo, treated in the ICU for 10-15 days without renal replacement therapy

Diagnostic Test: blood test

Interventions

blood test DIAGNOSTIC_TEST

Blood samples are drawn every 3-5 days in the RRT group but only once in the control group

CRRT patients; Non-CRRT patient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient of all ages treated with CRRT

You may qualify if:

• CRRT more than 5 days

You may not qualify if:

• N/A
• \- ICU care 10-15 days without any dialysis treatment

Sponsors & Collaborators

• Karolinska University Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma is sampled and stored in -80 degress C before analysis

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jonathan Grip, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Grip, MD, PhD

CONTACT

+46 73 623 09 06; jonathan.grip@regionstockholm.se

Kristina Kilsand, Research nurse

CONTACT

+46 8 123 810 03; kristina.kilsand@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share