Renal Physiology During Continuous Renal Replacement Therapy

NCT04114747 | Recruiting

• 1 other identifier: Kidney and dialysis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Contrast enhanced renal ultrasound (CEUS)

  2 hours

• atrial natriuretic peptide (ANP)

  6 hours

Study Arms (2)

Starting at high blood pressure

EXPERIMENTAL

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

Starting at low blood pressure

EXPERIMENTAL

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

Interventions

Starting at high or low blood pressure OTHER

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

Starting at high blood pressure; Starting at low blood pressure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Emergency need for dialysis Allergy to contrast media (used for CEUS)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristina Svennerholm, MD PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Svennerholm, MD PhD

CONTACT

+46313429336; kristina.svennerholm@vgregion.se

Christian Rylander, MD PhD

CONTACT

+46313421000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD

Model Details: To describe renal physiology parameters when starting CRRT and compare renal physiology parameters when using high blood pressure target (MAP 80-90 mmHg) and low blood pressure target (MAP 60-70 mmHg).

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 3, 2019
• Study Start: November 20, 2020
• Primary Completion: August 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)