Renal Physiology During Continuous Renal Replacement Therapy

Blood Pressure Clinical Trial

Official title:

Impact of Continuous Renal Replacement Therapy on Renal Oxygenation, Blood Flow and Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114747
• Other study ID #: Kidney and dialysis
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• AKI
• Blood Pressure
• Continuous Renal Replacement Therapy
• Dialysis
• Intensive Care
• Renal Blood Flow
• Renal Failure
• Renal Insufficiency

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