Acute Kidney InjuryNCT02455115
Renal Perfusion, Filtration and Oxygenation After Liver Transplantation -Effects of av Postoperative Blood Pressure
A study testing Alternating mean arterial pressure, Norepinephrine and Chromium ethylenediaminetetraacetic acid in people with Acute Kidney Injury and Liver Failure, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow, glomerular filtration rate and renal oxygen demand in patients with terminal liver failure directly after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Liver Failure
- What is being tested?
- Alternating mean arterial pressure, Norepinephrine and Chromium ethylenediaminetetraacetic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncomplicated liver transplantation
- Age over 18 years
- Given informed consent preoperatively
Who cannot join
- Veno-venous bypass intraoperatively
- Uncontrolled postoperative bleeding
- Circulatory stability without need for vasopressor treatment
- Pronounced circulatory or respiratory instability
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, dpt of anesthesiology and intensive care
Gothenburg, VGR, 41345
About this study
Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow, glomerular filtration rate and renal oxygen demand in patients with terminal liver failure directly after liver transplantation.
Read the detailed description
Patients with terminal liver failure are at risk to develop postoperative acute kidney injury (AKI) after liver transplantation. This is associated with augmented morbidity (CRRT/HD), and mortality. Hypotension perioperatively is a risk factor for the development of postoperative AKI.
In the investigators' study, the researchers aim to investigate the importance of the level of mean arterial pressure (MAP) on functional renal parameters directly after liver transplantation. 12 patients will be included after given informed and written consent.
Directly after the operation, the patients stay sedated and ventilated, have reached normovolaemia and are in need of vasopressor for adequate blood pressure. MAP is varied using the vasopressor norepinephrine.
Central hemodynamics will be measured using arterial catheter, PiCCO and a central vein catheter.
Renal data measures (RBF (renal blood flow), RPF (renal plasma flow), FF (filtration fraction), GFR (glomerular filtration rate), RVR (renal vascular resistance), Arterial-renal vein oxygen content difference, RVO2 (renal oxygen consumption), and RO2extr (Renal oxygen extraction)), are conducted via a renal vein thermodilution catheter: A 8-Fr catheter is introduced into the left or right renal vein, via the right femoral vein under fluoroscopic guidance, position being confirmed by venography using ultra-low doses of iohexol.
After the collection of blood and urine blanks, an intravenous priming dose of chromium ethylenediaminetetraacetic acid (51Cr-EDTA) is given, followed by an infusion at a constant rate, individualized to BSA and preoperative serum creatinine. Serum 51Cr-EDTA activity from arterial and renal vein blood is measured using a well counter. FF is measured as extraction of Cr-EDTA.
After one hour and two control measurements and urine/blood sampling on baseline MAP 75 mmHg, the investigators will randomise to continue to MAP 90 mmHg or 60 mmHg reached by altering the infusion rate of norepinephrine. Measurements, blood sampling and urine collection according to the above description, are performed after 30 min at each level, finishing at 75 mmHg with two control measurements with 30 mins in between.
- Conditions
- Acute Kidney Injury, Liver Failure
- Being tested
- Alternating mean arterial pressure, Norepinephrine, Chromium ethylenediaminetetraacetic acid
- Keywords
- Acute kidney injury, Liver transplantation, Postoperative care, Glomerular filtration rate, Renal blood flow, Vasopressor, Norepinephrine
- Medical subject headings
- Acute Kidney Injury, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating mean arterial pressureOther
Also called Norepinephrine
In normovolemic patients directly after liver transplantation, target mean arterial pressure is altered using norepinephrine according to study protocol.
NorepinephrineDrug
Also called Blood pressure control
Infusion rate of norepinephrine is raised and lowered, respectively, in order to reach MAP 60, 75 and 90 mmHg in patients already requiring vasopressor for adequate blood pressure control.
Chromium ethylenediaminetetraacetic acidDrug
Also called Infusion of 51Cr-EDTA
Extraction of 51Cr-EDTA measured for FF and GFR
| Study group | Role | What they receive |
|---|---|---|
| 60 mmHg | Experimental | Alternating mean arterial pressure by lowering of the infusion rate of norepinephrine Receives: Other: Alternating mean arterial pressure; Drug: Norepinephrine; Drug: Chromium ethylenediaminetetraacetic acid |
| 75 mmHg | Experimental | Alternating mean arterial pressure by adjust of the infusion rate of norepinephrine Receives: Other: Alternating mean arterial pressure; Drug: Norepinephrine; Drug: Chromium ethylenediaminetetraacetic acid |
| 90 mmHg | Experimental | Alternating mean arterial pressure by augmentation of the infusion rate of norepinephrine Receives: Other: Alternating mean arterial pressure; Drug: Norepinephrine; Drug: Chromium ethylenediaminetetraacetic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glomerular filtration rate (ml/min)
Change from baseline 75 mmHg to 60 and 90 mmHg, respectively
Measured: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Secondary outcomes (4)
Change in Renal blood flow (ml/min)
Measured via retrograde thermodilution catheter placed in renal vein. Change from baseline 75 mmHg to 60 and 90 mmHg, respectively.
Measured: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Change in Renal oxygen consumption (ml/min)
Blood samples and measurements of blood flow via retrograde thermodilution catheter placed in renal vein.
RBF × (CaO2-CrvO2) Change from baseline 75 mmHg to 60 and 90 mmHg, respectively
Measured: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Change in Filtration fraction (%)
Extraction of Cr-EDTA, blood samples from renal vein catheter. Change from baseline 75 mmHg to 60 and 90 mmHg, respectively.
Measured: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Change in Renal oxygen supply/demand relationship
Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2). Change from baseline 75 mmHg to 60 and 90 mmHg, respectively.
Measured: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Skytte Larsson, Sahlgrenska University Hospital
- Investigators
- Jenny Skytte Larsson, MD, Principal investigator, Sahlgrenska University HospitalSven-Erik Ricksten, Professor, Study chair, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455115
- Sponsor's protocol ID
- MAP after Livertransplantation
- Status last verified
- Sep 2016
- First submitted
- 23 Apr 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Skytte Larsson J, Bragadottir G, Redfors B, Ricksten SE. Renal function and oxygenation are impaired early after liver transplantation despite hyperdynamic systemic circulation. Crit Care. 2017 Apr 11;21(1):87. doi: 10.1186/s13054-017-1675-4.
PubMed 28395663
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Perfusion, Filtration and Oxygenation After Liver Transplantation -Effects of av Postoperative Blood Pressure
- ClinicalTrials.gov ID
- NCT02455115
- Acronym / sponsor ID
- MAP after Livertransplantation
- Conditions
- Acute Kidney Injury, Liver Failure
- Keywords
- Acute kidney injury, Liver transplantation, Postoperative care, Glomerular filtration rate, Renal blood flow, Vasopressor, Norepinephrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 May 2015 (estimated)
- 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.
Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow, glomerular filtration rate and renal oxygen demand in patients with terminal liver failure directly after liver transplantation.
Detailed description
Patients with terminal liver failure are at risk to develop postoperative acute kidney injury (AKI) after liver transplantation. This is associated with augmented morbidity (CRRT/HD), and mortality. Hypotension perioperatively is a risk factor for the development of postoperative AKI.
In the investigators' study, the researchers aim to investigate the importance of the level of mean arterial pressure (MAP) on functional renal parameters directly after liver transplantation. 12 patients will be included after given informed and written consent.
Directly after the operation, the patients stay sedated and ventilated, have reached normovolaemia and are in need of vasopressor for adequate blood pressure. MAP is varied using the vasopressor norepinephrine.
Central hemodynamics will be measured using arterial catheter, PiCCO and a central vein catheter.
Renal data measures (RBF (renal blood flow), RPF (renal plasma flow), FF (filtration fraction), GFR (glomerular filtration rate), RVR (renal vascular resistance), Arterial-renal vein oxygen content difference, RVO2 (renal oxygen consumption), and RO2extr (Renal oxygen extraction)), are conducted via a renal vein thermodilution catheter: A 8-Fr catheter is introduced into the left or right renal vein, via the right femoral vein under fluoroscopic guidance, position being confirmed by venography using ultra-low doses of iohexol.
After the collection of blood and urine blanks, an intravenous priming dose of chromium ethylenediaminetetraacetic acid (51Cr-EDTA) is given, followed by an infusion at a constant rate, individualized to BSA and preoperative serum creatinine. Serum 51Cr-EDTA activity from arterial and renal vein blood is measured using a well counter. FF is measured as extraction of Cr-EDTA.
After one hour and two control measurements and urine/blood sampling on baseline MAP 75 mmHg, the investigators will randomise to continue to MAP 90 mmHg or 60 mmHg reached by altering the infusion rate of norepinephrine. Measurements, blood sampling and urine collection according to the above description, are performed after 30 min at each level, finishing at 75 mmHg with two control measurements with 30 mins in between.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 mmHg | Experimental | Other: Alternating mean arterial pressure, Drug: Norepinephrine, Drug: Chromium ethylenediaminetetraacetic acidAlternating mean arterial pressure by lowering of the infusion rate of norepinephrine |
| 75 mmHg | Experimental | Other: Alternating mean arterial pressure, Drug: Norepinephrine, Drug: Chromium ethylenediaminetetraacetic acidAlternating mean arterial pressure by adjust of the infusion rate of norepinephrine |
| 90 mmHg | Experimental | Other: Alternating mean arterial pressure, Drug: Norepinephrine, Drug: Chromium ethylenediaminetetraacetic acidAlternating mean arterial pressure by augmentation of the infusion rate of norepinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Uncomplicated liver transplantation
- Age over 18 years
- Given informed consent preoperatively
Key exclusion criteria (4 listed)
- Veno-venous bypass intraoperatively
- Uncontrolled postoperative bleeding
- Circulatory stability without need for vasopressor treatment
- Pronounced circulatory or respiratory instability
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 |
|---|---|---|
| Alternating mean arterial pressureAlso: NorepinephrineIn normovolemic patients directly after liver transplantation, target mean arterial pressure is altered using norepinephrine according to study protocol. | Other | 60 mmHg, 75 mmHg, 90 mmHg |
| NorepinephrineAlso: Blood pressure controlInfusion rate of norepinephrine is raised and lowered, respectively, in order to reach MAP 60, 75 and 90 mmHg in patients already requiring vasopressor for adequate blood pressure control. | Drug | 60 mmHg, 75 mmHg, 90 mmHg |
| Chromium ethylenediaminetetraacetic acidAlso: Infusion of 51Cr-EDTAExtraction of 51Cr-EDTA measured for FF and GFR | Drug | 60 mmHg, 75 mmHg, 90 mmHg |
Primary outcome
Change in Glomerular filtration rate (ml/min)
Time frame: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Change from baseline 75 mmHg to 60 and 90 mmHg, respectively
4 secondary outcomes
Change in Renal blood flow (ml/min)
Time frame: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Change in Renal oxygen consumption (ml/min)
Time frame: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Change in Filtration fraction (%)
Time frame: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Change in Renal oxygen supply/demand relationship
Time frame: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 28395663Skytte Larsson J, Bragadottir G, Redfors B, Ricksten SE. Renal function and oxygenation are impaired early after liver transplantation despite hyperdynamic systemic circulation. Crit Care. 2017 Apr 11;21(1):87. doi: 10.1186/s13054-017-1675-4.
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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.
Jenny Skytte Larsson, MD principal investigator
Sahlgrenska University Hospital
Sven-Erik Ricksten, Professor study chair
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternating mean arterial pressure, Norepinephrine and Chromium ethylenediaminetetraacetic acid in people with Acute Kidney Injury and Liver Failure, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glomerular filtration rate (ml/min) (time frame: 60 min at baseline (75 mmHg), 30 min at randomized level 1(either 60 or 90 mmHg), 30 min at randomized level 2 (either 60 or 90 mmHg), 60 min after returning to baseline 75 mmHg again). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455115, which also lists 1 linked publication.
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 28 Sep 2016.