Electrolyte ImbalancesClinibilNCT02914782
Investigation of Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients
An observational study of Electrolyte Imbalances and Acute Kidney Injury, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Electrolyte Imbalances, Acute Kidney Injury
- What is being tested?
- Observational Study
- How many people
- 176 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2016to Oct 2022
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Monocentric Observational Study to Investigate Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients in the ICU
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.
Read the detailed description
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.
Due to the administration of large volumes of normal saline and/or a decreased urinary output of sodium or chloride iatrogen electrolyte disorders, such as hyperchloremic acidosis or dysnatremia are common abnormalities in the clinical practice. The common fact that normal saline has non-physiological levels of chloride and sodium, intensifies this problem with high volume administration. (Burdett et al. 2003; Adrogué \& Madias 1997).
Hypernatremia is an independent risk factor for mortality in critically ill patients and increases the length of ICU stay (Lindner et al. 2010; Stieglmair et al. 2013) Hypernatremia is associated with impaired renal fluid regulation, as well as a lack of thirst mechanisms. In the ICU this fact requires exact measurement of all fluid- and electrolyte intake and (non-)renal losses. (Lindner et al. 2009). Therefore, in critical care settings measuring fluid balance (the difference between infusion input and renal / non-renal losses) is daily routine. The renal output is measured frequently by the nursing staff. An automated acquisition of the urinary output combined with the data of the infusion site would reduce the workload of the staff and would allow visualization of the fluid status.
Furthermore, beyond volume, the concentration and composition of the fluid is an important parameter. The comparison of urinary electrolytes with the electrolyte input from infusions allows an early detection of electrolyte disorders (Besen et al. 2015). Sodium and chloride are the main ions of solutions infused into critically ill patients. The excessive infusion of fluids lead to sodium and chloride overloads and is associated with higher mortality (Noritomi et al. 2009). 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 also to measure the urinary electrolytes and its relative changes which are likely to be more relevant than the absolute electrolyte concentrations. Urinary electrolyte measurement may alert for the presence of AKI development before occurring increases in creatinine or oliguria (Maciel 2013; Maciel et al. 2015; Molitoris 2013).
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 (AKI).
Patients undergoing scheduled cardiac surgery will be included in this trial. The rationale behind this is on the one hand, that the patient cohort is homogenous and on the other hand, that the risk for developing an AKI is 30-40% among cardiac surgery patients (Rosner et al. 2006). The aim is to detect characteristic patterns in electrolyte metabolism between patients who develop an AKI and those who do not.
- Conditions
- Electrolyte Imbalances, Acute Kidney Injury
- Being tested
- Observational Study
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Electrolyte ImbalancesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG, Center for Biomarker Research in Medicine
- Responsible party
- Sponsor
- Investigators
- Philipp Eller, MD Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914782
- Sponsor's protocol ID
- 4947261
- Acronym
- Clinibil
- Status last verified
- Nov 2022
- First submitted
- 19 Sep 2016
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25938027Stieglmair 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.
PubMed 23890940Lindner 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.
PubMed 19515476Maciel 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.
PubMed 23384365Molitoris 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.
PubMed 24004539Maciel 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.
PubMed 26296826Adrogue HJ, Madias NE. Aiding fluid prescription for the dysnatremias. Intensive Care Med. 1997 Mar;23(3):309-16. doi: 10.1007/s001340050333.
PubMed 9083234Noritomi 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.
PubMed 19885998Rosner 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.
PubMed 17699187
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Monocentric Observational Study to Investigate Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients in the ICU
- ClinicalTrials.gov ID
- NCT02914782
- Acronym / sponsor ID
- Clinibil / 4947261
- Conditions
- Electrolyte Imbalances, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG, Center for Biomarker Research in Medicine
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Due to the administration of large volumes of normal saline and/or a decreased urinary output of sodium or chloride iatrogen electrolyte disorders, such as hyperchloremic acidosis or dysnatremia are common abnormalities in the clinical practice. The common fact that normal saline has non-physiological levels of chloride and sodium, intensifies this problem with high volume administration. (Burdett et al. 2003; Adrogué \& Madias 1997).
Hypernatremia is an independent risk factor for mortality in critically ill patients and increases the length of ICU stay (Lindner et al. 2010; Stieglmair et al. 2013) Hypernatremia is associated with impaired renal fluid regulation, as well as a lack of thirst mechanisms. In the ICU this fact requires exact measurement of all fluid- and electrolyte intake and (non-)renal losses. (Lindner et al. 2009). Therefore, in critical care settings measuring fluid balance (the difference between infusion input and renal / non-renal losses) is daily routine. The renal output is measured frequently by the nursing staff. An automated acquisition of the urinary output combined with the data of the infusion site would reduce the workload of the staff and would allow visualization of the fluid status.
Furthermore, beyond volume, the concentration and composition of the fluid is an important parameter. The comparison of urinary electrolytes with the electrolyte input from infusions allows an early detection of electrolyte disorders (Besen et al. 2015). Sodium and chloride are the main ions of solutions infused into critically ill patients. The excessive infusion of fluids lead to sodium and chloride overloads and is associated with higher mortality (Noritomi et al. 2009). 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 also to measure the urinary electrolytes and its relative changes which are likely to be more relevant than the absolute electrolyte concentrations. Urinary electrolyte measurement may alert for the presence of AKI development before occurring increases in creatinine or oliguria (Maciel 2013; Maciel et al. 2015; Molitoris 2013).
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 (AKI).
Patients undergoing scheduled cardiac surgery will be included in this trial. The rationale behind this is on the one hand, that the patient cohort is homogenous and on the other hand, that the risk for developing an AKI is 30-40% among cardiac surgery patients (Rosner et al. 2006). The aim is to detect characteristic patterns in electrolyte metabolism between patients who develop an AKI and those who do not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study | Other | – |
Primary outcome
Routine laboratory measurements and ELISA to define urinary and serum biomarkers for the early diagnosis of acute kidney injury.
Time frame: 1 year
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 secondary outcome
Measurement of fluid input and output (ml) to define trends in electrolyte and fluid balance using electronic data from ICU
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 25938027Besen 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.
- Background: PubMed 23890940Stieglmair 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.
- Background: PubMed 19515476Lindner 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.
- Background: PubMed 23384365Maciel 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.
- Background: PubMed 24004539Molitoris 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.
- Background: PubMed 26296826Maciel 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.
- Background: PubMed 9083234Adrogue HJ, Madias NE. Aiding fluid prescription for the dysnatremias. Intensive Care Med. 1997 Mar;23(3):309-16. doi: 10.1007/s001340050333.
- Background: PubMed 19885998Noritomi 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.
- Background: PubMed 17699187Rosner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Eller, MD Prof principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrolyte Imbalances and Acute Kidney Injury, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Routine laboratory measurements and ELISA to define urinary and serum biomarkers for the early diagnosis of acute kidney injury. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914782, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.