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Renal Physiology During Continuous Renal Replacement Therapy

Primary Purpose

AKI, Continuous Renal Replacement Therapy, Dialysis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Starting at high or low blood pressure
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for AKI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Starting at high blood pressure

Starting at low blood pressure

Arm Description

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

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

Outcomes

Primary Outcome Measures

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?
Renal blood flow and blood pressure
Renal blood flow changes at different mean arterial blood pressure targets during CRRT?
Glomerular filtration rate (GFR) and blood pressure
GFR changes at different mean arterial blood pressure targets during CRRT?
Glomerular filtration rate (GFR) and CRRT
Changes in GFR when CRRT is started?
Renal oxygenation during CRRT
Renal oxygenation before CRRT and during CRRT
Renal oxygenation and blood pressure
Renal oxygenation changes at different mean arterial blood pressure targets during CRRT?

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2019
Last Updated
April 10, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04114747
Brief Title
Renal Physiology During Continuous Renal Replacement Therapy
Official Title
Impact of Continuous Renal Replacement Therapy on Renal Oxygenation, Blood Flow and Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AKI, Continuous Renal Replacement Therapy, Dialysis, Intensive Care, Renal Blood Flow, Renal Failure, Blood Pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Starting at high blood pressure
Arm Type
Experimental
Arm Description
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
Arm Title
Starting at low blood pressure
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Starting at high or low blood pressure
Intervention Description
Using norepinephrine, patients will receive high or low blood pressure to start with and after measurements cross to receive the other blood pressure target
Primary Outcome Measure Information:
Title
Renal blood flow and CRRT
Description
Changes in renal blood flow when CRRT is started? How will renal blood flow and oxygenation change at different blood pressure targets?
Time Frame
6 hours
Title
Renal blood flow and blood pressure
Description
Renal blood flow changes at different mean arterial blood pressure targets during CRRT?
Time Frame
6 hours
Title
Glomerular filtration rate (GFR) and blood pressure
Description
GFR changes at different mean arterial blood pressure targets during CRRT?
Time Frame
6 hours
Title
Glomerular filtration rate (GFR) and CRRT
Description
Changes in GFR when CRRT is started?
Time Frame
6 hours
Title
Renal oxygenation during CRRT
Description
Renal oxygenation before CRRT and during CRRT
Time Frame
6 hours
Title
Renal oxygenation and blood pressure
Description
Renal oxygenation changes at different mean arterial blood pressure targets during CRRT?
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Contrast enhanced renal ultrasound (CEUS)
Description
Validation of CEUS compared to retrograde renal vein thermodilution in measuring renal blood flow
Time Frame
2 hours
Title
atrial natriuretic peptide (ANP)
Description
Differences in serum atrial natriuretic peptide (ANP) during CRRT
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Svennerholm, MD PhD
Phone
+46313429336
Email
kristina.svennerholm@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Rylander, MD PhD
Phone
+46313421000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Svennerholm, MD PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Svennerholm, MD PhD
Phone
+46313429336
Email
kristina.svennerholm@vgregion.se
First Name & Middle Initial & Last Name & Degree
Oskar Juvakka, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Renal Physiology During Continuous Renal Replacement Therapy

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