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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04114747
Other study ID # Kidney and dialysis
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Sahlgrenska University Hospital, Sweden
Contact Kristina Svennerholm, MD PhD
Phone +46313429336
Email kristina.svennerholm@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Approximately 50% of patients in the intensive care unit (ICU) develop acute kidney injury (AKI) and more than 10% need dialysis. There is no treatment for AKI. Care is aiming for optimization of circulation and blood flow to the kidneys and avoiding nephrotoxic agents. There is conflicting data concerning whether early or late dialysis is harmful for the kidneys. No one has examined the physiological changes in the kidney when starting dialysis and which blood pressure that leads to most optimal physiological conditions for the kidneys during dialysis. In this descriptive study of 20 ICU patients suffering from AKI we aim to investigate renal physiology when starting continuous renal replacement therapy (CRRT) and also at different target blood pressures using retrograde renal vein thermodilution technique. In parallel we will also investigate and validate this invasive method with contrast enhanced ultrasound of the kidneys.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2025
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: AKI, according to KDIGO, stage 2 or 3 but with preserved urine production. Treated in the ICU at Sahlgrenska University Hospital Written, signed informed consent Male and female subjects =18 years Exclusion Criteria: Emergency need for dialysis Allergy to contrast media (used for CEUS)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Starting at high or low blood pressure
Using norepinephrine, patients will receive high or low blood pressure to start with and after measurements cross to receive the other blood pressure target

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal blood flow and CRRT Changes in renal blood flow when CRRT is started? How will renal blood flow and oxygenation change at different blood pressure targets? 6 hours
Primary Renal blood flow and blood pressure Renal blood flow changes at different mean arterial blood pressure targets during CRRT? 6 hours
Primary Glomerular filtration rate (GFR) and blood pressure GFR changes at different mean arterial blood pressure targets during CRRT? 6 hours
Primary Glomerular filtration rate (GFR) and CRRT Changes in GFR when CRRT is started? 6 hours
Primary Renal oxygenation during CRRT Renal oxygenation before CRRT and during CRRT 6 hours
Primary Renal oxygenation and blood pressure Renal oxygenation changes at different mean arterial blood pressure targets during CRRT? 6 hours
Secondary Contrast enhanced renal ultrasound (CEUS) Validation of CEUS compared to retrograde renal vein thermodilution in measuring renal blood flow 2 hours
Secondary atrial natriuretic peptide (ANP) Differences in serum atrial natriuretic peptide (ANP) during CRRT 6 hours
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