ClinicalTrials.gg
Status unknownNCT04114747Updated Apr 18, 2024

Renal Physiology During Continuous Renal Replacement Therapy

An interventional study of Starting at high or low blood pressure in AKI, Continuous Renal Replacement Therapy and Dialysis, sponsored by Sahlgrenska University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Browse trials for

03

In context

Renal Insufficiency

2,030 studies on the registry are indexed under Renal Insufficiency; 168 are open to participants now.

This study's planned enrollment of 20 is below the median of 43 across 1,534 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherStarting 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

06

What researchers measure

Primary outcomes

  1. 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?

    Time frame: 6 hours

  2. Renal blood flow and blood pressure

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

    Time frame: 6 hours

  3. Glomerular filtration rate (GFR) and blood pressure

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

    Time frame: 6 hours

  4. Glomerular filtration rate (GFR) and CRRT

    Changes in GFR when CRRT is started?

    Time frame: 6 hours

  5. Renal oxygenation during CRRT

    Renal oxygenation before CRRT and during CRRT

    Time frame: 6 hours

  6. Renal oxygenation and blood pressure

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

    Time frame: 6 hours

Secondary outcomes

  1. Contrast enhanced renal ultrasound (CEUS)

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

    Time frame: 2 hours

  2. atrial natriuretic peptide (ANP)

    Differences in serum atrial natriuretic peptide (ANP) during CRRT

    Time frame: 6 hours

07

Study locations

1 of 1 sites recruiting
  • Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Aug 2025, 57 months after the start.

Of 186 non-industry interventional studies with no phase under Renal Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's planned 57 months is above that.

Counting every sponsor, half of 218 studies reached it within 22 months; a quarter within 8 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2019
First posted
Oct 3, 2019
StartActual
Nov 20, 2020
Primary completionEst.
Aug 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04114747
Responsible party
Kristina Svennerholm (Principal investigator, MD, PhD, Sahlgrenska University Hospital) — Principal investigator
First posted
Oct 3, 2019
Start date
Nov 20, 2020
Primary completion
Aug 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 18, 2024

Study contacts

Kristina Svennerholm, MD PhD
Contact
kristina.svennerholm@vgregion.se
+46313429336
Christian Rylander, MD PhD
Contact
+46313421000
Kristina Svennerholm, MD PhD
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion