Acute Kidney Injury Clinical Trial
— ClinibilOfficial title:
An Open Monocentric Observational Study to Investigate Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients in the ICU
NCT number | NCT02914782 |
Other study ID # | 4947261 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | October 2022 |
Verified date | November 2022 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Critically ill patients need intravenous fluid therapy in order to correct or prevent problems with their fluid and/or electrolyte status and for renal protection. The decision for the optimal composition and amount of IV-fluids can be difficult and complex. It is well known that errors in fluid- and electrolyte management contribute to overall morbidity and mortality. For decades, urinary sodium was used to diagnose renal disease. Nevertheless, renal excretion of sodium is largely impaired in critically ill patients, particularly in patients with acute kidney injury. Due to the high frequent measurement of renal output, it would be possible to measure the urinary electrolytes and its relative changes. Urinary electrolyte measurement may alert for the presence of the development of an akute kidney injury before occurring increases in creatinine or oliguria. The rationale of this investigation is therefore to collect data related to fluid- and electrolyte management from critically ill patients in order to find patterns of fluid- and electrolyte imbalances which may lead to disturbances and further, may allow an early detection of acute kidney injury.
Status | Completed |
Enrollment | 176 |
Est. completion date | October 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: i. 8 years or older ii. Expected length of stay at the ICU > 48 hours iii. eGFR (CKD-EPI) > 45 ml/min iv. ACR < 300 mg/g creatinine v. signed informed consent prior to cardiac surgery Exclusion Criteria: i. renal insufficiency (eGFR-CKD-EPI < 45 ml/min), dialysis ii. severe infection (fever > 38 °C, CRP > 50 ml/l) iii. increased risk for perioperative multi-organ failure due to co-morbidities such as cardiogenic decompensation pre-surgery, low cardiac output, incipient cardiogenic shock and sepsis iv. Karnofsky Index < 40 v. hearing impairment vi. physical and mental illnesses vii. missing signed informed consent |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Graz | Graz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz | B. Braun Melsungen AG, Center for Biomarker Research in Medicine |
Austria,
Adrogué HJ, Madias NE. Aiding fluid prescription for the dysnatremias. Intensive Care Med. 1997 Mar;23(3):309-16. — View Citation
Besen BA, Gobatto AL, Melro LM, Maciel AT, Park M. Fluid and electrolyte overload in critically ill patients: An overview. World J Crit Care Med. 2015 May 4;4(2):116-29. doi: 10.5492/wjccm.v4.i2.116. eCollection 2015 May 4. Review. — View Citation
Lindner G, Kneidinger N, Holzinger U, Druml W, Schwarz C. Tonicity balance in patients with hypernatremia acquired in the intensive care unit. Am J Kidney Dis. 2009 Oct;54(4):674-9. doi: 10.1053/j.ajkd.2009.04.015. Epub 2009 Jun 10. — View Citation
Maciel AT, Nassar AP Jr, Vitorio D. Very Transient Cases of Acute Kidney Injury in the Early Postoperative Period After Cardiac Surgery: The Relevance of More Frequent Serum Creatinine Assessment and Concomitant Urinary Biochemistry Evaluation. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):56-63. doi: 10.1053/j.jvca.2015.04.020. Epub 2015 Apr 28. — View Citation
Maciel AT. Breaking old and new paradigms regarding urinary sodium in acute kidney injury diagnosis and management. Crit Care. 2013 Feb 4;17(1):115. doi: 10.1186/cc11926. Review. — View Citation
Molitoris BA. Measuring glomerular filtration rate in the intensive care unit: no substitutes please. Crit Care. 2013 Sep 4;17(5):181. doi: 10.1186/cc12876. — View Citation
Noritomi DT, Soriano FG, Kellum JA, Cappi SB, Biselli PJ, Libório AB, Park M. Metabolic acidosis in patients with severe sepsis and septic shock: a longitudinal quantitative study. Crit Care Med. 2009 Oct;37(10):2733-9. — View Citation
Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. Epub 2005 Oct 19. Review. — View Citation
Stieglmair S, Lindner G, Lassnigg A, Mouhieddine M, Hiesmayr M, Schwarz C. Body salt and water balances in cardiothoracic surgery patients with intensive care unit-acquired hyponatremia. J Crit Care. 2013 Dec;28(6):1114.e1-5. doi: 10.1016/j.jcrc.2013.05.017. Epub 2013 Jul 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Routine laboratory measurements and ELISA to define urinary and serum biomarkers for the early diagnosis of acute kidney injury. | Serum and urine will be collected multiple times daily and analyzed for Na, K, Osmolality, Cl and oxygen concentration. Serum and urine ELISA assays will be carried out to detect changes in concentration of KIM-1, NGAL, Cystatin-C and E-Selectin. | 1 year | |
Secondary | Measurement of fluid input and output (ml) to define trends in electrolyte and fluid balance using electronic data from ICU | Define how renal status correlates with the electrolyte balance of the patient by analyzing trend curves of fluid input (ml of infusion solution, ml parenteral nutrition, etc.) and output (ml urine, ml drainages, etc.) over the course of the stay at the ICU. The data will be entered manually into a software program routinely used at the ICU. | 1 year |
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