Investigation of Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients

NCT02914782 | Completed

• 1 other identifier: 4947261
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Electrolyte Imbalances; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of fluid input and output (ml) to define trends in electrolyte and fluid balance using electronic data from ICU

  1 year

Interventions

Observational Study OTHER

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 adult patients (\<18 years, m\&f) will be included in this study. All patients will be assigned with randomized numbers to stay anonymous. Patients scheduled for cardiac-surgery with normal renal function will be included to assure a homogenous clinical picture. These patients will be transferred to the intensive care unit post-surgery where electrolyte and fluid data will be collected along with serum and urine samples. The will remain in the study only during their stay at the ICU.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• B. Braun Melsungen AG: collaborator
• Center for Biomarker Research in Medicine: collaborator

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (9)

• 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.

  PMID: 25938027 BACKGROUND

• 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.

  PMID: 23890940 BACKGROUND

• 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.

  PMID: 19515476 BACKGROUND

• 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.

  PMID: 23384365 BACKGROUND

• 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.

  PMID: 24004539 BACKGROUND

• 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.

  PMID: 26296826 BACKGROUND

• Adrogue HJ, Madias NE. Aiding fluid prescription for the dysnatremias. Intensive Care Med. 1997 Mar;23(3):309-16. doi: 10.1007/s001340050333.

  PMID: 9083234 BACKGROUND

• Noritomi DT, Soriano FG, Kellum JA, Cappi SB, Biselli PJ, Liborio 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. doi: 10.1097/ccm.0b013e3181a59165.

  PMID: 19885998 BACKGROUND

• Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19.

  PMID: 17699187 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

In the course of the stay at the ICU we will collect serum and urine samples during routine patient care to analyze for electrolytes, oxygen and kidney biomarkers.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Philipp Eller, MD Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

AU (1)