AKINCT04114747
Renal Physiology During Continuous Renal Replacement Therapy
A study testing Starting at high or low blood pressure in people with AKI and Continuous Renal Replacement Therapy, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- AKI, Continuous Renal Replacement Therapy, Dialysis
- What is being tested?
- Starting at high or low blood pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 20 Nov 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Emergency need for dialysis Allergy to contrast media (used for CEUS)
Trial locations and contacts
1 site in 1 country.
Christian Rylander, MD PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Kristina Svennerholm, MD PhD, +46313429336, kristina.svennerholm@vgregion.se
Oskar Juvakka, MD
About this study
Official title: 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.
- Conditions
- AKI, Continuous Renal Replacement Therapy, Dialysis, Intensive Care, Renal Blood Flow, Renal Failure
- Being tested
- Starting at high or low blood pressure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting at high or low blood pressureOther
Using norepinephrine, patients will receive high or low blood pressure to start with and after measurements cross to receive the other blood pressure target
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Starting at high or low blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 6 hours
Renal blood flow and blood pressure
Renal blood flow changes at different mean arterial blood pressure targets during CRRT?
Measured: 6 hours
Glomerular filtration rate (GFR) and blood pressure
GFR changes at different mean arterial blood pressure targets during CRRT?
Measured: 6 hours
Glomerular filtration rate (GFR) and CRRT
Changes in GFR when CRRT is started?
Measured: 6 hours
Renal oxygenation during CRRT
Renal oxygenation before CRRT and during CRRT
Measured: 6 hours
Renal oxygenation and blood pressure
Renal oxygenation changes at different mean arterial blood pressure targets during CRRT?
Measured: 6 hours
Secondary outcomes (2)
Contrast enhanced renal ultrasound (CEUS)
Validation of CEUS compared to retrograde renal vein thermodilution in measuring renal blood flow
Measured: 2 hours
atrial natriuretic peptide (ANP)
Differences in serum atrial natriuretic peptide (ANP) during CRRT
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start20 Nov 2020
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Svennerholm, Sahlgrenska University Hospital
- Investigators
- Kristina Svennerholm, MD PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114747
- Sponsor's protocol ID
- Kidney and dialysis
- Status last verified
- Apr 2024
- First submitted
- 23 Sep 2019
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Renal Replacement Therapy on Renal Oxygenation, Blood Flow and Function
- ClinicalTrials.gov ID
- NCT04114747
- Acronym / sponsor ID
- Kidney and dialysis
- Conditions
- AKI, Continuous Renal Replacement Therapy, Dialysis, Intensive Care, Renal Blood Flow, Renal Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Starting at high blood pressure | Experimental | Other: Starting at high or low blood pressurePatients 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 |
| Starting at low blood pressure | Experimental | Other: Starting at high or low blood pressurePatients 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Emergency need for dialysis Allergy to contrast media (used for CEUS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starting at high or low blood pressureUsing norepinephrine, patients will receive high or low blood pressure to start with and after measurements cross to receive the other blood pressure target | Other | Starting at high blood pressure, Starting at low blood pressure |
Primary outcome
Renal blood flow and CRRT
Time frame: 6 hours
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
Time frame: 6 hours
Renal blood flow changes at different mean arterial blood pressure targets during CRRT?
Glomerular filtration rate (GFR) and blood pressure
Time frame: 6 hours
GFR changes at different mean arterial blood pressure targets during CRRT?
Glomerular filtration rate (GFR) and CRRT
Time frame: 6 hours
Changes in GFR when CRRT is started?
Renal oxygenation during CRRT
Time frame: 6 hours
Renal oxygenation before CRRT and during CRRT
Renal oxygenation and blood pressure
Time frame: 6 hours
Renal oxygenation changes at different mean arterial blood pressure targets during CRRT?
2 secondary outcomes
Contrast enhanced renal ultrasound (CEUS)
Time frame: 2 hours
atrial natriuretic peptide (ANP)
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Rylander, MD PhD contact
Kristina Svennerholm, MD PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starting at high or low blood pressure in people with AKI and Continuous Renal Replacement Therapy, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Svennerholm, MD PhD (+46313429336, kristina.svennerholm@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal blood flow and CRRT (time frame: 6 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.