New Prognostic Kidney Function Markers in Emergency Patients New Markers of Kidney Function in ED Patients

Acute Kidney Injury Clinical Trial

Official title:

New Prognostic Kidney Function Markers in Emergency Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02261909
• Other study ID #: 1
• Status: Withdrawn
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2022
• Source: Krankenhaus Barmherzige Brüder, Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast Media
• Emergencies

Locations

Country	Name	City	State
Germany	Krankenhaus Barmherzige Brueder	Regensburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Brüder, Regensburg	Astute Medical, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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

Outcome

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