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

NCT02261909 | Withdrawn

• 1 other identifier: 1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Contrast Media

Keywords

Emergency Medicine; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Requirement for dialysis

  participants will be followed for the duration of hospital stay, an expected average of 7 days

• Admission to ICU

  participants will be followed for the duration of hospital stay, an expected average of 7 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• patients in the emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer.

You may not qualify if:

• children, pregnant women
• dialysis
• patients with kidney transplants
• patients on steroids or further immunocompromised

Sponsors & Collaborators

• Krankenhaus Barmherzige Brüder, Regensburg: lead
• Astute Medical, Inc.: collaborator

Study Sites (1)

Krankenhaus Barmherzige Brueder

Regensburg, Bavaria, 93049, Germany

Location

Related Publications (7)

• 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.

  PMID: 24675717 BACKGROUND

• 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.

  PMID: 24578125 BACKGROUND

• 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.

  PMID: 23394211 BACKGROUND

• 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.

  PMID: 23394215 BACKGROUND

• 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.

  PMID: 24933630 BACKGROUND

• 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.

  PMID: 24559465 BACKGROUND

• 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, 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.

  PMID: 23388612 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, urine

MeSH Terms

Conditions

Acute Kidney Injury; Disease

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Braess, Prof

  Krankenhaus Barmherzige Brüder

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 10, 2014
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

DE (1)