Renal Physiology During Continuous Renal Replacement Therapy

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina Svennerholm, MD PhD; Phone Number: +46313429336; Email: kristina.svennerholm@vgregion.se
• Study Contact Backup: Name: Christian Rylander, MD PhD; Phone Number: +46313421000

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Kristina Svennerholm, MD PhD; Phone Number: +46313429336; Email: kristina.svennerholm@vgregion.se
    • Principal Investigator: Oskar Juvakka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Starting at high 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	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
Experimental: Starting at 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Renal blood flow and blood pressure	Renal blood flow changes at different mean arterial blood pressure targets during CRRT?	6 hours
Glomerular filtration rate (GFR) and blood pressure	GFR changes at different mean arterial blood pressure targets during CRRT?	6 hours
Glomerular filtration rate (GFR) and CRRT	Changes in GFR when CRRT is started?	6 hours
Renal oxygenation during CRRT	Renal oxygenation before CRRT and during CRRT	6 hours
Renal oxygenation and blood pressure	Renal oxygenation changes at different mean arterial blood pressure targets during CRRT?	6 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Kristina Svennerholm, MD PhD

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: Kidney and dialysis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No