AKI in Thoracic and Abdominal Surgery
29 mars 2018 mis à jour par: Anthony Bonavia, Milton S. Hershey Medical Center
Acute Kidney Injury and Nonsteroidal Anti-inflammatory Drugs in Patients Undergoing High-risk Abdominal or Thoracic Surgery
The study will investigate the role of NSAIDs in the development of AKI in patients undergoing high-risk abdominal or thoracic surgery.
The investigators hypothesize that the use of new urinary biomarkers will allow earlier detection of AKI than the current gold standard, i.e. changes in serum creatinine and/or urine output.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
This study will be designed as a prospective observational trial. After obtaining Institutional Review Board (IRB) approval, patients will be recruited and consented from the Anesthesia Pre-Operative Clinic. On the day of surgery, baseline urine samples will be obtained at the initial insertion of the Foley catheter, after induction of anesthesia. Urine samples will also be collected from the Foley catheter in the immediate post-operative period shortly after the patient is admitted to the Intensive Care Unit (ICU). Urine samples will continue to be collected for 72 hours post-operatively, at 0600 (6am) and 1800 (6pm) each day from the indwelling Foley catheter, which is standard of care in the ICU. Urine samples will be labeled and stored as per the instructions provided in a commercially available kit; six urine samples total will be collected and stored per patient. The electronic medical record (EMR) will be reviewed to determine whether the patient received ketorolac, ibuprofen, or no NSAIDs intra-operatively and postoperatively (within 72 hours of the beginning of surgery). Daily serum creatinine measurements and hourly urine output, which are standards of care in the ICU, will be obtained from the EMR as well.
AKI will be diagnosed and staged according to KDIGO criteria, which are based on changes in creatinine and urine output. In all patients with "KDIGO-diagnosed AKI" and in a matched non-AKI group, we will also compare the time course of new urinary biomarkers, including but not limited to uNGAL, to that of serum creatinine and urine output. We will match patients according to their demographics as well as clinical characteristics, including co-morbidities, type of surgery and anesthesia technique. Comparing the time course of current clinical markers (serum creatinine and urine output) with that of new urinary biomarkers will allow us to assess their role in guiding future preventive interventions.
Type d'étude
Observationnel
Inscription (Réel)
50
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Pennsylvania
-
Hershey, Pennsylvania, États-Unis, 17033
- Penn State Milton S Hershey Medical Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Subjects will be identified by surgeon and by length of procedure.
Patients presenting to the Anesthesia Preoperative Clinic who are scheduled to have surgery lasting longer than 4 hours by certain surgeons, and who are anticipated to recover postoperatively in the Surgical Intensive Care Unit will be given a recruitment/consent form explaining the study.
The study will then be explained to potential patients by a member of the research team to determine recruitment eligibility and willingness to participate.
La description
Inclusion Criteria:
- age ≥ 21 (per manufacturer's instructions on the Nephrocheck kit)
- history of hypertension, whether medically treated or untreated
- scheduled for Anesthesia preoperative clinic visit
- scheduled to undergo prolonged intra-abdominal or intra-thoracic surgeries (defined as scheduled intraoperative time ≥ 4h). Intra-abdominal surgeries will include colorectal surgery, massive ventral hernia repairs, hepatobiliary surgery and gynecologic-oncology surgery. Intra-thoracic surgeries will include video-assisted thoracoscopic surgery (VATS)-assisted segmentectomy and lobectomies, as well as mediastinal mass excisions.
- will be anticipated to be admitted to the ICU for a minimum of 2-3 days post-operatively
Exclusion Criteria:
- history of chronic kidney as defined by estimated glomerular filtration rate (GFR) <90
- patient taking NSAIDs on a daily basis
- patients with a reported allergy or intolerance to NSAIDs
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Ketorolac
Patients who receive ketorolac perioperatively
|
|
Caldolor
Patients who receive Caldolor perioperatively
|
|
No NSAIDS
Patients who do not receive NSAIDS perioperatively
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acute Kidney Injury
Délai: 72 hours post-operatively
|
AKI defined by change in serum creatinine from baseline and change in urine output (KDIGO criteria)
|
72 hours post-operatively
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Urine biomarkers in AKI detection
Délai: 72 hours post-operatively
|
Our secondary analysis will investigate the performance of new FDA approved urine biomarkers including, but not limited to, uNGAL (urinary neutrophil gelatinase associated lipocalin) in AKI detection.
|
72 hours post-operatively
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Anthony Bonavia, MD, Milton S. Hershey Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
- Devarajan P. Update on mechanisms of ischemic acute kidney injury. J Am Soc Nephrol. 2006 Jun;17(6):1503-20. doi: 10.1681/ASN.2006010017. Epub 2006 May 17. No abstract available.
- Rodier F, Campisi J, Bhaumik D. Two faces of p53: aging and tumor suppression. Nucleic Acids Res. 2007;35(22):7475-84. doi: 10.1093/nar/gkm744. Epub 2007 Oct 16.
- Boonstra J, Post JA. Molecular events associated with reactive oxygen species and cell cycle progression in mammalian cells. Gene. 2004 Aug 4;337:1-13. doi: 10.1016/j.gene.2004.04.032.
- 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.
- 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.
- 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.
- Luo X, Jiang L, Du B, Wen Y, Wang M, Xi X; Beijing Acute Kidney Injury Trial (BAKIT) workgroup. A comparison of different diagnostic criteria of acute kidney injury in critically ill patients. Crit Care. 2014 Jul 8;18(4):R144. doi: 10.1186/cc13977.
- Forrest JB, Camu F, Greer IA, Kehlet H, Abdalla M, Bonnet F, Ebrahim S, Escolar G, Jage J, Pocock S, Velo G, Langman MJ, Bianchi PG, Samama MM, Heitlinger E; POINT Investigators. Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. Br J Anaesth. 2002 Feb;88(2):227-33. doi: 10.1093/bja/88.2.227.
- Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
- Gocze I, Koch M, Renner P, Zeman F, Graf BM, Dahlke MH, Nerlich M, Schlitt HJ, Kellum JA, Bein T. Urinary biomarkers TIMP-2 and IGFBP7 early predict acute kidney injury after major surgery. PLoS One. 2015 Mar 23;10(3):e0120863. doi: 10.1371/journal.pone.0120863. eCollection 2015.
- Calvert S, Shaw A. Perioperative acute kidney injury. Perioper Med (Lond). 2012 Jul 4;1:6. doi: 10.1186/2047-0525-1-6. eCollection 2012.
- Witzgall R, Brown D, Schwarz C, Bonventre JV. Localization of proliferating cell nuclear antigen, vimentin, c-Fos, and clusterin in the postischemic kidney. Evidence for a heterogenous genetic response among nephron segments, and a large pool of mitotically active and dedifferentiated cells. J Clin Invest. 1994 May;93(5):2175-88. doi: 10.1172/JCI117214.
- Yang QH, Liu DW, Long Y, Liu HZ, Chai WZ, Wang XT. Acute renal failure during sepsis: potential role of cell cycle regulation. J Infect. 2009 Jun;58(6):459-64. doi: 10.1016/j.jinf.2009.04.003. Epub 2009 Apr 17.
- Lafrance JP, Miller DR. Selective and non-selective non-steroidal anti-inflammatory drugs and the risk of acute kidney injury. Pharmacoepidemiol Drug Saf. 2009 Oct;18(10):923-31. doi: 10.1002/pds.1798.
- Zipser RD, Hoefs JC, Speckart PF, Zia PK, Horton R. Prostaglandins: modulators of renal function and pressor resistance in chronic liver disease. J Clin Endocrinol Metab. 1979 Jun;48(6):895-900. doi: 10.1210/jcem-48-6-895.
- Huerta C, Castellsague J, Varas-Lorenzo C, Garcia Rodriguez LA. Nonsteroidal anti-inflammatory drugs and risk of ARF in the general population. Am J Kidney Dis. 2005 Mar;45(3):531-9. doi: 10.1053/j.ajkd.2004.12.005.
- Patrono C, Dunn MJ. The clinical significance of inhibition of renal prostaglandin synthesis. Kidney Int. 1987 Jul;32(1):1-12. doi: 10.1038/ki.1987.164. No abstract available.
- Arora S, Wagner JG, Herbert M. Myth: parenteral ketorolac provides more effective analgesia than oral ibuprofen. CJEM. 2007 Jan;9(1):30-2. doi: 10.1017/s1481803500014718. No abstract available.
- Zarbock A, Meersch M, Van Aken H, Gorlich D, Singbartl K. Urinary hyaluronic acid as an early predictor of acute kidney injury after cardiac surgery. J Am Coll Cardiol. 2014 Aug 19;64(7):737-8. doi: 10.1016/j.jacc.2014.05.034. No abstract available.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2016
Achèvement primaire (Réel)
23 mars 2018
Achèvement de l'étude (Réel)
23 mars 2018
Dates d'inscription aux études
Première soumission
15 septembre 2015
Première soumission répondant aux critères de contrôle qualité
16 septembre 2015
Première publication (Estimation)
17 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mars 2018
Dernière vérification
1 mars 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00003086
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Lésion rénale aiguë
-
Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne