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Renal Physiology During Continuous Renal Replacement Therapy

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Recruiting
CT.gov ID
NCT04114747
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
37.3
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Starting at high or low blood pressure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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).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).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Continuous Renal Replacement Therapy on Renal Oxygenation, Blood Flow and Function
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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?

  2. Renal blood flow and blood pressure [6 hours]

    Renal blood flow changes at different mean arterial blood pressure targets during CRRT?

  3. Glomerular filtration rate (GFR) and blood pressure [6 hours]

    GFR changes at different mean arterial blood pressure targets during CRRT?

  4. Glomerular filtration rate (GFR) and CRRT [6 hours]

    Changes in GFR when CRRT is started?

  5. Renal oxygenation during CRRT [6 hours]

    Renal oxygenation before CRRT and during CRRT

  6. Renal oxygenation and blood pressure [6 hours]

    Renal oxygenation changes at different mean arterial blood pressure targets during CRRT?

Secondary Outcome Measures

  1. Contrast enhanced renal ultrasound (CEUS) [2 hours]

    Validation of CEUS compared to retrograde renal vein thermodilution in measuring renal blood flow

  2. atrial natriuretic peptide (ANP) [6 hours]

    Differences in serum atrial natriuretic peptide (ANP) during CRRT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sahlgrenska University Hospital Gothenburg Sweden 41345

Sponsors and Collaborators

  • Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Kristina Svennerholm, MD PhD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristina Svennerholm, Principal investigator, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT04114747
Other Study ID Numbers:
  • Kidney and dialysis
First Posted:
Oct 3, 2019
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency

Study Results

No Results Posted as of Mar 2, 2022