Renal Physiology During Continuous Renal Replacement Therapy

Not Applicable

Recruiting

• Conditions: Continuous Renal Replacement Therapy; Dialysis; Intensive Care; Renal Failure; AKI; Blood Pressure; Renal Blood Flow
• Interventions: Other: Starting at high or low blood pressure

• Registration Number: NCT04114747
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Study Start: 2020-11-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Starting at high blood pressure	Starting at high or low blood pressure	Patients in this arm are randomized to have high target blood pressure at MAP 80-90 mmHg during the first recordings, thereafter they will receive low blood pressure target 60-70 mm Hg
Starting at low blood pressure	Starting at high or low blood pressure	Patients in this arm are randomized to have low target blood pressure at MAP 60-70 mmHg during the first recordings, thereafter they will receive high blood pressure target 80-90 mm Hg

Primary Outcome Measures

Name	Time	Method
Renal blood flow and CRRT	6 hours	Changes in renal blood flow when CRRT is started? How will renal blood flow and oxygenation change at different blood pressure targets?
Renal blood flow and blood pressure	6 hours	Renal blood flow changes at different mean arterial blood pressure targets during CRRT?
Renal oxygenation during CRRT	6 hours	Renal oxygenation before CRRT and during CRRT
Glomerular filtration rate (GFR) and blood pressure	6 hours	GFR changes at different mean arterial blood pressure targets during CRRT?
Glomerular filtration rate (GFR) and CRRT	6 hours	Changes in GFR when CRRT is started?
Renal oxygenation and blood pressure	6 hours	Renal oxygenation changes at different mean arterial blood pressure targets during CRRT?

Secondary Outcome Measures

Name	Time	Method
Contrast enhanced renal ultrasound (CEUS)	2 hours	Validation of CEUS compared to retrograde renal vein thermodilution in measuring renal blood flow
atrial natriuretic peptide (ANP)	6 hours	Differences in serum atrial natriuretic peptide (ANP) during CRRT

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden