Diabetic Kidney DiseaseCROCODILENCT04074668
Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
An observational study of Diabetic Kidney Disease and Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the development of diabetic kidney disease (DKD) and which contribute to reduced life expectancy. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Kidney Disease, Type 1 Diabetes, Diabetes
- What is being tested?
- Aminohippurate Sodium Inj 20%, Iohexol Inj 300 milligrams/milliliter (mg/ml) and PET/CT Scan
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 15 Nov 2022
- Phase
- Observational
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We propose to address the specific aims of this study in a cross-sectional project with 30 adults with T1D and 20 controls (50% female, ages 18-30 yr).
Who may be able to join
- Antibody positive Type 1 Diabetes with duration > 5 years
- BMI between 18.5 and 30 kg/m2
- Weight < 350 lbs
- HbA1c < 11%
- Hemoglobin >= 12 g/dl
- No diagnosis of Type 1 or Type 2 Diabetes
Show all 10Show fewer
- BMI between 18.5 and 30 kg/m2
- Weight < 350 lbs
- HbA1c < 11%
- Hemoglobin >= 12 g/dl
Who cannot join
- Recent diagnosis (within 3 months) of Diabetic Ketoacidosis (DKA)
- Severe illness
- Pregnancy, nursing
- Anemia
- Allergy to shellfish or iodine
- Claustrophobia or implantable metal devices (MRI contraindications)
Show all 34Show fewer
- High blood pressure (greater than 130/80 mm Hg)
- Elevated Urine Albumin-to-Creatinine Ratio (UACR) (>30 mg/g) or estimated Glomerular Filtration Rate (eGFR) <90 ml/min/1.73 m2
- Taking ACE inhibitors (ACEis), Angiotensin receptor blockers (ARBs), diuretics, Sodium Glucose Transporter (SGLT) 1/2 blockers
- Severe illness
- Pregnancy, nursing
- Anemia
- Allergy to shellfish or iodine
- Claustrophobia or implantable metal devices (MRI contraindications)
- High blood pressure (greater than 130/80 mm Hg)
- Elevated UACR (>30 mg/g) or eGFR <90 ml/min/1.73 m2
- Taking ACE inhibitors (ACEis), Angiotensin receptor blockers (ARBs), diuretics, SGLT 1/2 blockers
- Additional exclusion criteria for participants undergoing optional kidney biopsy:
- Evidence of bleeding disorder or complications from bleeding
- Use of aspirin, NSAIDS or other blood thinner that cannot be safely stopped for a sufficient time period before and after the biopsy so as to add no additional risk of bleeding
- Blood urea nitrogen (BUN) > 80 gm/dL
- INR > 1.4
- PTT > 35 seconds
- Hemoglobin (Hgb) < 10 mg/dL
- Platelet count < 100,000 / µL
- Uncontrolled or difficult to control hypertension (> 150/90 mmHg at the day of biopsy)
- eGFR < 40 mL/min/1.73m2
- Single kidney (either by history, documented by prior imaging or ultrasound performed prior to the biopsy)
- > 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter determined by ultrasound performed prior to the biopsy.
- Kidney size: One or both kidneys < 9 cm
- Hydronephrosis or other important renal ultrasound findings such as significant stone disease
- Any evidence of a current urinary tract infection as indicated on day of biopsy
- Clinical evidence of non-diabetic renal disease
- Positive urine pregnancy test or pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: CROCODILE Study: Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the development of diabetic kidney disease (DKD) and which contribute to reduced life expectancy. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. By examining the interplay between factors responsible for increased renal adenosine triphosphate (ATP) consumption and decreased ATP generation in young adults with and without T1D, this study hopes to identify novel therapeutic targets to impede the development of DKD in future trials.
The investigators propose to address the specific aims in a cross-sectional study with 30 adults with T1D and 20 controls without a diagnosis of diabetes. For this protocol, participants will complete a one day study visit at Children's Hospital Colorado. Patients will undergo a Dual-energy X-Ray Absorptiometry (DXA) scan to assess body composition, renal Magnetic Resonance Imaging (MRI) to quantify renal oxygenation and perfusion, and a Positron Emission Tomography/Computed Tomography (PET/CT) scan to quantify renal O2 consumption. After the PET and MRI, participants will undergo a hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the hyperinsulinemic-euglycemic clamp. To further investigate the mechanisms of renal damage in T1D, two optional procedures are included in the study: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.
- Conditions
- Diabetic Kidney Disease, Type 1 Diabetes, Diabetes, Diabetes Mellitus, Diabetes Complications, Diabetic Nephropathies
- Being tested
- Aminohippurate Sodium Inj 20%, Iohexol Inj 300 milligrams/milliliter (mg/ml), PET/CT Scan, Renal Biopsy
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1, Diabetes Mellitus, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminohippurate Sodium Inj 20%Drug
Also called Sodium 4-amino hippurate (PAH) inj 20% 2 grams (g)/10 milliliters (mL), Para-aminohippurate, Aminohippuric acid
Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
Iohexol Inj 300 milligrams/milliliter (mg/ml)Drug
Also called omnipaque 300
Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
PET/CT ScanRadiation
Imaging used to visualize the kidneys and quantify renal metabolic activity
Renal BiopsyProcedure or surgery
Minimally invasive outpatient procedure to obtain renal tissue after ultrasound visualization.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | All participants will undergo DXA scan, magnetic resonance imaging (MRI) studies of the kidneys, PET/CT using 11-C acetate to measure renal oxygen consumption, hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity, and renal clearance testing using iohexol and para-aminohippurate (PAH) to quantify glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). Receives: Drug: Aminohippurate Sodium Inj 20%; Drug: Iohexol Inj 300 milligrams/milliliter (mg/ml); Radiation: PET/CT Scan; Procedure: Renal Biopsy | |
| Healthy Controls | All participants will undergo DXA scan, magnetic resonance imaging (MRI) studies of the kidneys, PET/CT using 11-C acetate to measure renal oxygen consumption, hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity, and renal clearance testing using iohexol and para-aminohippurate (PAH) to quantify glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). Receives: Drug: Aminohippurate Sodium Inj 20%; Drug: Iohexol Inj 300 milligrams/milliliter (mg/ml); Radiation: PET/CT Scan; Procedure: Renal Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Oxygenation
Blood oxygen level dependent (BOLD) MRI
Measured: 30 minutes
Renal Perfusion
Arterial Spin Labeling (ASL) MRI
Measured: 30 minutes
Renal Oxygen Consumption
11-C Acetate PET/CT
Measured: 30 minutes
Insulin Sensitivity
Hyperinsulinemic-Euglycemic Clamp
Measured: 4.5 hours
Mitochondrial Function
Blood draw for mitochondrial DNA copy number
Measured: 5 minutes
Mitochondrial Function
Blood draw for untargeted metabolite assessment of the tricyclic acid (TCA) cycle
Measured: 5 minutes
Mitochondrial Function
Blood draw for targeted assessment and quantification of glucose oxidation using an established metabolite panel
Measured: 5 minutes
Mitochondrial Function
Blood draw for untargeted metabolite assessment of Free Fatty Acid (FFA) oxidation
Measured: 5 minutes
Secondary outcomes (10)
Glomerular Filtration Rate (GFR)
Iohexol Clearance Study
Measured: 3 hours
Effective Renal Plasma Flow (ERPF)
PAH Clearance Study
Measured: 2.5 hours
Renin-Angiotensin-Aldosterone-System Activity
Blood draw for Plasma Renin levels
Measured: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Blood draw for Angiotensin II levels
Measured: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Blood draw for Copeptin levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Tyrosine Lysine Leucine-40 (YKL-40) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Neutrophil gelatinase-associated lipocalin (NGAL) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Kidney Injury Marker 1 (KIM-1) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Interleukin-18 (IL-18) levels
Measured: 5 minutes
Kidney Injury Biomarkers
Blood draw for Tumor Necrosis Factor Receptor 1/2 (TNF-R 1/2) levels
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Jan 2020
- Primary completion15 May 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074668
- Sponsor's protocol ID
- 19-1282
- Acronym
- CROCODILE
- Status last verified
- Feb 2023
- First submitted
- 6 Aug 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi YJ, Richard G, Zhang G, Hodgin JB, Demeke DS, Yang Y, Schaub JA, Tamayo IM, Gurung BK, Naik AS, Nair V, Birznieks C, MacDonald A, Narongkiatikhun P, Gross S, Driscoll L, Flynn M, Tommerdahl K, Nadeau KJ, Shah VN, Vigers T, Snell-Bergeon JK, Kendrick J, van Raalte DH, Li LP, Prasad P, Ladd P, Chin BB, Cherney DZ, McCown PJ, Alakwaa F, Otto EA, Brosius FC, Saulnier PJ, Puelles VG, Goodrich JA, Street K, Venkatachalam MA, Ruiz A, de Boer IH, Nelson RG, Pyle L, Blondin DP, Sharma K, Kretzler M, Bjornstad P. Attenuated kidney oxidative metabolism in young adults with type 1 diabetes. J Clin Invest. 2024 Oct 22;134(24):e183984. doi: 10.1172/JCI183984.
PubMed 39436695Bjornstad P, Richard G, Choi YJ, Nowak KL, Steele C, Chonchol MB, Nadeau KJ, Vigers T, Pyle L, Tommerdahl K, van Raalte DH, Hilkin A, Driscoll L, Birznieks C, Hopp K, Wang W, Edelstein C, Nelson RG, Gregory AV, Kline TL, Blondin D, Gitomer B. Kidney Energetics and Cyst Burden in Autosomal Dominant Polycystic Kidney Disease: A Pilot Study. Am J Kidney Dis. 2024 Sep;84(3):286-297.e1. doi: 10.1053/j.ajkd.2024.02.016. Epub 2024 Apr 15.
PubMed 38621633
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CROCODILE Study: Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
- ClinicalTrials.gov ID
- NCT04074668
- Acronym / sponsor ID
- CROCODILE / 19-1282
- Conditions
- Diabetic Kidney Disease, Type 1 Diabetes, Diabetes, Diabetes Mellitus, Diabetes Complications, Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 30 Aug 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.
Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the development of diabetic kidney disease (DKD) and which contribute to reduced life expectancy. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. By examining the interplay between factors responsible for increased renal adenosine triphosphate (ATP) consumption and decreased ATP generation in young adults with and without T1D, this study hopes to identify novel therapeutic targets to impede the development of DKD in future trials.
The investigators propose to address the specific aims in a cross-sectional study with 30 adults with T1D and 20 controls without a diagnosis of diabetes. For this protocol, participants will complete a one day study visit at Children's Hospital Colorado. Patients will undergo a Dual-energy X-Ray Absorptiometry (DXA) scan to assess body composition, renal Magnetic Resonance Imaging (MRI) to quantify renal oxygenation and perfusion, and a Positron Emission Tomography/Computed Tomography (PET/CT) scan to quantify renal O2 consumption. After the PET and MRI, participants will undergo a hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the hyperinsulinemic-euglycemic clamp. To further investigate the mechanisms of renal damage in T1D, two optional procedures are included in the study: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | Drug: Aminohippurate Sodium Inj 20%, Drug: Iohexol Inj 300 milligrams/milliliter (mg/ml), Radiation: PET/CT Scan, Procedure: Renal BiopsyAll participants will undergo DXA scan, magnetic resonance imaging (MRI) studies of the kidneys, PET/CT using 11-C acetate to measure renal oxygen consumption, hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity, and renal clearance testing using iohexol and para-aminohippurate (PAH) to quantify glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). |
| Healthy Controls | – | Drug: Aminohippurate Sodium Inj 20%, Drug: Iohexol Inj 300 milligrams/milliliter (mg/ml), Radiation: PET/CT Scan, Procedure: Renal BiopsyAll participants will undergo DXA scan, magnetic resonance imaging (MRI) studies of the kidneys, PET/CT using 11-C acetate to measure renal oxygen consumption, hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity, and renal clearance testing using iohexol and para-aminohippurate (PAH) to quantify glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We propose to address the specific aims of this study in a cross-sectional project with 30 adults with T1D and 20 controls (50% female, ages 18-30 yr).
Key inclusion criteria (10 listed)
- Antibody positive Type 1 Diabetes with duration > 5 years
- BMI between 18.5 and 30 kg/m2
- Weight < 350 lbs
- HbA1c < 11%
- Hemoglobin >= 12 g/dl
Key exclusion criteria (34 listed)
- Recent diagnosis (within 3 months) of Diabetic Ketoacidosis (DKA)
- Severe illness
- Pregnancy, nursing
- Anemia
- Allergy to shellfish or iodine
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 |
|---|---|---|
| Aminohippurate Sodium Inj 20%Also: Sodium 4-amino hippurate (PAH) inj 20% 2 grams (g)/10 milliliters (mL), Para-aminohippurate, Aminohippuric acidDiagnostic aid/agent used to measure effective renal plasma flow (ERPF) | Drug | Healthy Controls, Type 1 Diabetes |
| Iohexol Inj 300 milligrams/milliliter (mg/ml)Also: omnipaque 300Diagnostic aid/agent used to measure glomerular filtration rate (GFR) | Drug | Healthy Controls, Type 1 Diabetes |
| PET/CT ScanImaging used to visualize the kidneys and quantify renal metabolic activity | Radiation | Healthy Controls, Type 1 Diabetes |
| Renal BiopsyMinimally invasive outpatient procedure to obtain renal tissue after ultrasound visualization. | Procedure or surgery | Healthy Controls, Type 1 Diabetes |
Primary outcome
Renal Oxygenation
Time frame: 30 minutes
Blood oxygen level dependent (BOLD) MRI
Renal Perfusion
Time frame: 30 minutes
Arterial Spin Labeling (ASL) MRI
Renal Oxygen Consumption
Time frame: 30 minutes
11-C Acetate PET/CT
Insulin Sensitivity
Time frame: 4.5 hours
Hyperinsulinemic-Euglycemic Clamp
Mitochondrial Function
Time frame: 5 minutes
Blood draw for mitochondrial DNA copy number
Mitochondrial Function
Time frame: 5 minutes
Blood draw for untargeted metabolite assessment of the tricyclic acid (TCA) cycle
Mitochondrial Function
Time frame: 5 minutes
Blood draw for targeted assessment and quantification of glucose oxidation using an established metabolite panel
Mitochondrial Function
Time frame: 5 minutes
Blood draw for untargeted metabolite assessment of Free Fatty Acid (FFA) oxidation
10 secondary outcomes
Glomerular Filtration Rate (GFR)
Time frame: 3 hours
Effective Renal Plasma Flow (ERPF)
Time frame: 2.5 hours
Renin-Angiotensin-Aldosterone-System Activity
Time frame: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Time frame: 5 minutes
Renin-Angiotensin-Aldosterone-System Activity
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
Kidney Injury Biomarkers
Time frame: 5 minutes
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 9 Feb 2023.
- Derived from this study: PubMed 39436695Choi YJ, Richard G, Zhang G, Hodgin JB, Demeke DS, Yang Y, Schaub JA, Tamayo IM, Gurung BK, Naik AS, Nair V, Birznieks C, MacDonald A, Narongkiatikhun P, Gross S, Driscoll L, Flynn M, Tommerdahl K, Nadeau KJ, Shah VN, Vigers T, Snell-Bergeon JK, Kendrick J, van Raalte DH, Li LP, Prasad P, Ladd P, Chin BB, Cherney DZ, McCown PJ, Alakwaa F, Otto EA, Brosius FC, Saulnier PJ, Puelles VG, Goodrich JA, Street K, Venkatachalam MA, Ruiz A, de Boer IH, Nelson RG, Pyle L, Blondin DP, Sharma K, Kretzler M, Bjornstad P. Attenuated kidney oxidative metabolism in young adults with type 1 diabetes. J Clin Invest. 2024 Oct 22;134(24):e183984. doi: 10.1172/JCI183984.
- Derived from this study: PubMed 38621633Bjornstad P, Richard G, Choi YJ, Nowak KL, Steele C, Chonchol MB, Nadeau KJ, Vigers T, Pyle L, Tommerdahl K, van Raalte DH, Hilkin A, Driscoll L, Birznieks C, Hopp K, Wang W, Edelstein C, Nelson RG, Gregory AV, Kline TL, Blondin D, Gitomer B. Kidney Energetics and Cyst Burden in Autosomal Dominant Polycystic Kidney Disease: A Pilot Study. Am J Kidney Dis. 2024 Sep;84(3):286-297.e1. doi: 10.1053/j.ajkd.2024.02.016. Epub 2024 Apr 15.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease and Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
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 10 inclusion and 34 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 9 Feb 2023. 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 United States. 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?
Renal Oxygenation (time frame: 30 minutes). The study lists 8 primary outcomes in all. 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 NCT04074668, which also lists 2 linked publications.
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 9 Feb 2023; AzTrials last refreshed its copy on 26 Oct 2026.