Acute Kidney InjuryNCT02261909
New Prognostic Kidney Function Markers in Emergency Patients New Markers of Kidney Function in ED Patients
An observational study of Acute Kidney Injury and Contrast Media, run by Krankenhaus Barmherzige Brüder, Regensburg at 1 site in Germany.
Trial summary
NephroCheck is measuring the concentration of a certain protein combination in the urine of patients. In elevated values there is a probability of renal failure (already proven in intensive care patients). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Contrast Media
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the in emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer.
Who may be able to join
- patients in the emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer.
Who cannot join
- children, pregnant women
- dialysis
- patients with kidney transplants
- patients on steroids or further immunocompromised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Prognostic Kidney Function Markers in Emergency Patients
NephroCheck is measuring the concentration of a certain protein combination in the urine of patients. In elevated values there is a probability of renal failure (already proven in intensive care patients). The investigators would like to investigate whether the investigators can predict renal failure in patients receiving contrast enhanced CT's in the emergency department. That would lead to an earlier nephrologist consult in those patients.
Read the detailed description
The use of contrast agents can - especially in already in impaired renal function - lead to a decline in real function. The contrast enhanced CT is especially in emergency patients an important diagnostic tool for example in the detection of pulmonary embolism or mesenteric ischemia. Creatinine has been used as a marker for real function so far. But the investigators all know that creatinine is not a perfect marker especially as it is influenced by age, sex, weight and muscle mass. Especially in the diagnosis of acute renal failure creatinine does not allow and recent change in the kidney function.
This prospective, unicentric study should therefore investigate two new markers in emergency patients who need an emergency contrast enhanced CT to early predict pending kidney function decline.
- Conditions
- Acute Kidney Injury, Contrast Media
- Keywords
- Emergency Medicine, diagnosis
- Medical subject headings
- Acute Kidney Injury, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal creatinine | pts receiving an iv-contrast enhanced CT with normal baseline renal function | |
| elevated creatinine | pts receiving an iv-contrast enhanced CT with abnormal baseline renal function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
renal function at discharge from hospital (creatinine and BUN measured at day of discharge)
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes (2)
Requirement for dialysis
dialysis required throughout hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Admission to ICU
admission to ICU required throughout hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: Study failed to receive final approvement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Brüder, Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Astute Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Jan Braess, Prof, Study chair, Krankenhaus Barmherzige Brüder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261909
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2022
- First submitted
- 3 Oct 2014
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.
PubMed 24675717Olden M, Corre T, Hayward C, Toniolo D, Ulivi S, Gasparini P, Pistis G, Hwang SJ, Bergmann S, Campbell H, Cocca M, Gandin I, Girotto G, Glaudemans B, Hastie ND, Loffing J, Polasek O, Rampoldi L, Rudan I, Sala C, Traglia M, Vollenweider P, Vuckovic D, Youhanna S, Weber J, Wright AF, Kutalik Z, Bochud M, Fox CS, Devuyst O. Common variants in UMOD associate with urinary uromodulin levels: a meta-analysis. J Am Soc Nephrol. 2014 Aug;25(8):1869-82. doi: 10.1681/ASN.2013070781. Epub 2014 Feb 27.
PubMed 24578125Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
PubMed 23394211Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.
PubMed 23394215Risch L, Lhotta K, Meier D, Medina-Escobar P, Nydegger UE, Risch M. The serum uromodulin level is associated with kidney function. Clin Chem Lab Med. 2014 Dec;52(12):1755-61. doi: 10.1515/cclm-2014-0505.
PubMed 24933630Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.
PubMed 24559465Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
PubMed 23388612
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Prognostic Kidney Function Markers in Emergency Patients
- ClinicalTrials.gov ID
- NCT02261909
- Acronym / sponsor ID
- 1
- Conditions
- Acute Kidney Injury, Contrast Media
- Keywords
- Emergency Medicine, diagnosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study failed to receive final approvement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Brüder, RegensburgUniversity, hospital or other
- Collaborators
- Astute Medical, Inc.
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Oct 2014 (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.
NephroCheck is measuring the concentration of a certain protein combination in the urine of patients. In elevated values there is a probability of renal failure (already proven in intensive care patients). The investigators would like to investigate whether the investigators can predict renal failure in patients receiving contrast enhanced CT's in the emergency department. That would lead to an earlier nephrologist consult in those patients.
Detailed description
The use of contrast agents can - especially in already in impaired renal function - lead to a decline in real function. The contrast enhanced CT is especially in emergency patients an important diagnostic tool for example in the detection of pulmonary embolism or mesenteric ischemia. Creatinine has been used as a marker for real function so far. But the investigators all know that creatinine is not a perfect marker especially as it is influenced by age, sex, weight and muscle mass. Especially in the diagnosis of acute renal failure creatinine does not allow and recent change in the kidney function.
This prospective, unicentric study should therefore investigate two new markers in emergency patients who need an emergency contrast enhanced CT to early predict pending kidney function decline.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal creatinine | – | –pts receiving an iv-contrast enhanced CT with normal baseline renal function |
| elevated creatinine | – | –pts receiving an iv-contrast enhanced CT with abnormal baseline renal function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the in emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer.
Key inclusion criteria (1 listed)
- patients in the emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer.
Key exclusion criteria (4 listed)
- children, pregnant women
- dialysis
- patients with kidney transplants
- patients on steroids or further immunocompromised
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal function
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
renal function at discharge from hospital (creatinine and BUN measured at day of discharge)
2 secondary outcomes
Requirement for dialysis
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Admission to ICU
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 24675717Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.
- Background: PubMed 24578125Olden M, Corre T, Hayward C, Toniolo D, Ulivi S, Gasparini P, Pistis G, Hwang SJ, Bergmann S, Campbell H, Cocca M, Gandin I, Girotto G, Glaudemans B, Hastie ND, Loffing J, Polasek O, Rampoldi L, Rudan I, Sala C, Traglia M, Vollenweider P, Vuckovic D, Youhanna S, Weber J, Wright AF, Kutalik Z, Bochud M, Fox CS, Devuyst O. Common variants in UMOD associate with urinary uromodulin levels: a meta-analysis. J Am Soc Nephrol. 2014 Aug;25(8):1869-82. doi: 10.1681/ASN.2013070781. Epub 2014 Feb 27.
- Background: PubMed 23394211Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
- Background: PubMed 23394215Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.
- Background: PubMed 24933630Risch L, Lhotta K, Meier D, Medina-Escobar P, Nydegger UE, Risch M. The serum uromodulin level is associated with kidney function. Clin Chem Lab Med. 2014 Dec;52(12):1755-61. doi: 10.1515/cclm-2014-0505.
- Background: PubMed 24559465Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.
- Background: PubMed 23388612Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
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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.
Jan Braess, Prof study chair
Krankenhaus Barmherzige Brüder
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 Acute Kidney Injury and Contrast Media, run by Krankenhaus Barmherzige Brüder, Regensburg at 1 site in Germany.
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 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: withdrawn, as of the sponsor's last update on 22 Aug 2022. 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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 function (time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days). 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 NCT02261909, which also lists 7 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 22 Aug 2022.