Acute Kidney Injury Clinical Trial
Official title:
New Prognostic Kidney Function Markers in Emergency Patients
NCT number | NCT02261909 |
Other study ID # | 1 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | June 2016 |
Verified date | August 2022 |
Source | Krankenhaus Barmherzige Brüder, Regensburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients in the emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer. Exclusion Criteria: - children, pregnant women - dialysis - patients with kidney transplants - patients on steroids or further immunocompromised |
Country | Name | City | State |
---|---|---|---|
Germany | Krankenhaus Barmherzige Brueder | Regensburg | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Krankenhaus Barmherzige Brüder, Regensburg | Astute Medical, Inc. |
Germany,
Bihorac 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. — View Citation
Kashani 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, Rimmelé 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. — View Citation
Kellum 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. Review. — View Citation
Lameire 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. Review. — View Citation
Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Görlich 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. — View Citation
Olden 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. — View Citation
Risch 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal function | renal function at discharge from hospital (creatinine and BUN measured at day of discharge) | participants will be followed for the duration of hospital stay, an expected average of 7 days | |
Secondary | Requirement for dialysis | dialysis required throughout hospital stay | participants will be followed for the duration of hospital stay, an expected average of 7 days | |
Secondary | Admission to ICU | admission to ICU required throughout hospital stay | participants will be followed for the duration of hospital stay, an expected average of 7 days |
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