Renal Physiology During Continuous Renal Replacement Therapy

NCT ID: NCT04114747

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Starting at high or low blood pressure

Intervention Type: 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 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

Group Type: EXPERIMENTAL

Starting at high or low blood pressure

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristina Svennerholm

Principal investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristina Svennerholm, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Kristina Svennerholm, MD PhD

Role: CONTACT

kristina.svennerholm@vgregion.se

+46313429336

Christian Rylander, MD PhD

Role: CONTACT

+46313421000

Facility Contacts

Kristina Svennerholm, MD PhD

Role: primary

kristina.svennerholm@vgregion.se

+46313429336

Other Identifiers

Kidney and dialysis

Identifier Type: -

Identifier Source: org_study_id