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Renal Replacement Therapy RICH study NCT02669589

- 6/27/16 - 1 form, 4 itemgroups, 36 items, 1 language
Itemgroups: Patient Information, Dialysis information, Dialysis flow, Catheter: Adjustment
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Stuivenberg Hospital Acute Renal Failure (SHARF) II score T0 - Stuivenberg Hospital Acute Renal Failure (SHARF) II score T48

- 1/25/18 - 2 forms, 1 itemgroup, 9 items, 1 language
Itemgroup: SHARF score T48
A prognostic scoring system for hospital mortality in acute renal failure (Stuivenberg Hospital Acute Renal Failure, SHARF score) was developed in a single-centre study. The scoring system consists of two scores, for the time of diagnosis of acute renal failure (ARF) and for 48 h later, each originally based on four parameters (age, serum albumin, prothrombin time and heart failure). The SHARF II score is the result of a re-evaluation and modification and includes three more variables (serum bilirubin, sepsis and hypotension). References: Lins, R. L., Elseviers, M. M., Daelemans, R., Arnouts, P., Billiouw, J. M., Couttenye, M., ... & De Broe, M. E. (2004). Re-evaluation and modification of the Stuivenberg Hospital Acute Renal Failure (SHARF) scoring system for the prognosis of acute renal failure: an independent multicentre, prospective study. Nephrology dialysis transplantation, 19(9), 2282-2288. Lins, R. L., Elseviers, M., Daelemans, R., Zachée, P., Gheuens, E., Lens, S., & De Broe, M. E. (2000). Prognostic value of a new scoring system for hospital mortality in acute renal failure. Clin Nephrol, 53(1), 10-7.

Stuivenberg Hospital Acute Renal Failure (SHARF) II score T0

1 itemgroup 9 items

dbGaP phs000894 Genome Wide Study of Vancomycin - pht004658.v1.p1

- 4/2/24 - 5 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht004658
Principal Investigator: Dan Roden, MD, Vanderbilt University Medical Center, Nashville, TN, USA MeSH: Acute Kidney Injury https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000894 The goal of this study was to identify genetic variants associated with risk for acute kidney injury (AKI) in patients being treated with vancomycin and genetic variants associated with variability in vancomycin pharmacokinetics. AKI is a common adverse drug event and known complication of vancomycin therapy. Known risk factors fail to accurately predict renal toxicity. Our hypothesis, that genetic variants modify the risk of AKI, was tested by performing genome-wide association and linear regression in 429 patients of European descent using the outcome of peak serum creatinine while on vancomycin. We also tested the hypothesis that genetic variants associate with vancomycin pharmacokinetics, using vancomycin trough levels and calculated renal elimination rate constant as outcomes.

pht004659.v1.p1

1 itemgroup 3 items

pht004660.v1.p1

1 itemgroup 5 items

pht004661.v1.p1

1 itemgroup 4 items

Eligibility

1 itemgroup 1 item

SAE Form RICH study NCT02669589

- 9/20/21 - 1 form, 9 itemgroups, 51 items, 1 language
Itemgroups: Patient Information, Seriousness criteria, Serious Adverse Event (SAE), Treatment of SAE, Drugs, Relevant Medical History, Tests and procedures, Comments, Investigator
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Protocol violation RICH study NCT02669589

- 7/8/16 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Patient Information, Protocol violation, Identification and Signature
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Adverse Event: Heparin RICH study NCT02669589

- 7/8/16 - 1 form, 6 itemgroups, 21 items, 1 language
Itemgroups: Patient Information, Adverse Event Description, Duration, Therapy, Comments, Case report form data
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Adverse Event: Citrate RICH study NCT02669589 - Adverse Event: Citrat RICH study NCT02669589

- 7/8/16 - 1 form, 6 itemgroups, 21 items, 1 language
Itemgroups: Patient Information, Adverse Event Description, Duration, Therapy, Comments, Case report form data
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Pre-Screening Log RICH study NCT02669589

- 7/8/16 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Patient Information, Inclusion Criteria, Reason for Exclusion
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

End of Therapy RICH study NCT02669589

- 7/1/16 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Patient Information, End of Therapy, End of documentation, Hospital stay
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Visit documentation RICH study NCT02669589

- 6/27/16 - 1 form, 12 itemgroups, 139 items, 1 language
Itemgroups: Patient Information, Documentation period, Adverse Event, Glasgow Coma Scale, Mechanical ventilation, Catecholamine and inotropic therapy, Clinical Data, Concomitant medication, Laboratory Parameters and Blood Gas Analysis, Fluid balance, Transfusion, Microbiology
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Visit documentation: Day 1-14; Day 21+28 Study Chair: Alexander Zarbock, MD University Hospital Muenster

Consent RICH study NCT02669589

- 7/4/16 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Patient Information, Subsequent consent, Withdrawal of consent
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Follow Up RICH study NCT02669589

- 7/2/16 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Patient Information, Folllow Up, Renal Replacement Therapy
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

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