An observational study in Acute Kidney Injury, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by University Hospital Ostrava · Observational
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Among 16 studies in Acute Kidney Injury with a site in Czechia — 5 open to participants now, 5 under way, 1 of them phase 3. Acute Kidney Injury · Czechia.
Among the 16 studies in Acute Kidney Injury with a site in Czechia, this one is the only one that started in 2013, is one of 8 observational ones, and was the 4th registered.
1,691 studies on the registry are indexed under Acute Kidney Injury; 394 are open to participants now.
Browse Acute Kidney Injury studies →5 of the 16 studies in Acute Kidney Injury with a site in Czechia are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Czechia, United States, Argentina and 11 more countries
Ages 18–80
Fresenius Medical Care Deutschland GmbH · Sites in Czechia, Germany
Ages up to 18
Region Örebro County · Sites in Czechia, Denmark, Sweden
Ages 18+
University Hospital Ostrava · Sites in Czechia
Ages 18+
Indiana University · Sites in Czechia, United States, Argentina and 30 more countries
Ages 0 min–2 wk
A study can be open while its sites in Czechia have not opened yet or have stopped. Only those recruiting at a site in Czechia →
Of the 230 Acute Kidney Injury studies recruiting now, 161 (70%) set no upper age limit and 36 (16%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 81 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Median enrollment 151 across the 8 interventional studies, 135 across the 8 observational. Of the 10 that completed or were terminated, 3 (30%) have results posted.
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7 of 16 have an industry lead sponsor. The 10 most frequent:
University Hospital Ostrava is the lead sponsor of 149 studies on the registry; 51 are open to participants now.
University Hospital Ostrava has 5 studies filed under Acute Kidney Injury — fewer than ten, so there is no comparison to draw.
2 of the studies in Acute Kidney Injury with a site in Czechia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT07215702AstraZenecaA Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. | 2027-02-11 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Acute Kidney Injury with a site in Czechia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Acute kidney injury (AKI) represents a serious complication following severe injury associated with adverse outcome. Main goals of the presented study were to define the incidence of AKI and to evaluate the validity of AKI biomarker neutrophil gelatinase-associated lipocalin (NGAL) in AKI prediction in severely injured patients. Secondary goals were to determine the time-dependent role of injury-related tissue hypoxia, systemic inflammatory response, and rhabdomyolysis in the pathophysiology of AKI.
The main goal of the presented study was to define the epidemiology of AKI and to evaluate the validity of AKI biomarker neutrophil gelatinase-associated lipocalin in AKI prediction in severely injured patients with Injury Severity Score (ISS) > 24. Secondary goals were to determine the time-dependent role of insults associated directly with the intensity of injury (tissue hypoxia, systemic inflammatory response and/or infection, rhabdomyolysis) in the pathophysiology of AKI.
The study was performed in a single center at the University Hospital in Ostrava in the Czech Republic. The Ethics Committee of the University Hospital Ostrava approved the study, which conformed to the tenets of the Declaration of Helsinki. Each of the awake and conscious study subjects signed the Informed Consent Form approved by the Ethics Committee of the University Hospital Ostrava. For enrolment of unconscious study subjects who were unable to sign informed consent, approval of two independent (i.e. not involved in the study) physicians was needed.
Patients and methods: All adult severely injured patients defined by Injury Severity Scale (ISS) > 24 admitted to the Department of Anaesthesiology and Intensive Care in University Hospital Ostrava between June 2013 and December 2015 were enrolled into the study. Subjects were screened for AKI presence defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria daily up to 8 days after injury. Arterial levels of neutrophil gelatinase-associated lipocalin (NGAL), lactate, interleukin-6 (IL-6), procalcitonin (PCT) and myoglobin were investigated at the time points 24 hours (T1), 48 hours (T2) and 96 hours (T3) after injury.
Methods All consecutive severely injured patients (ISS > 24) older than 18 years of age were enrolled in this prospective observational study between June 2013 and December 2015. All participants were admitted to the Level 1 Trauma Centre (Department of Anaesthesiology and Critical Care) at the University Hospital of Ostrava. Exclusion criteria included age \< 18 years, history of kidney disease, pregnancy, death within 24 hours after injury, unsurvivable injury with an end of life decision (withhold or withdraw of therapy) pronounced within 24 hours after injury and, finally, clinical signs of brain death within 24 hours after injury.
Basic observed demographic parameters included age, ISS and mechanism of injury. The laboratory parameters included blood NGAL; arterial lactate level, IL-6, PCT and myoglobin at the 24 hours (T1), 48 hours (T2) and 96 hours (T3) after injury. Serum Creatinine level was assessed once daily at 6.00 a.m. and urine output collected hourly from admission (D0) to Day 8 were the basis for evaluation of AKI presence. Because of the recent pre-injury values of Creatinine were unknown almost in all of the subjects, first serum Creatinine level (sCr) taken on admission to the emergency room was used as a baseline reference value.
All diagnostic and therapeutic interventions were performed in accordance with guidelines and standards for the treatment of the critically injured patients. The study protocol does not contain any additional diagnostic or therapeutic intervention except the laboratory investigations mentioned above.
Early AKI defined according to KDIGO criteria occurs in one-third of victims of severe injury. Blood NGAL levels during the first 96 hours after injury are significantly higher in patients who subsequently develop AKI. Prolonged tissue hypoxia, excessive and prolonged activation of inflammatory response and rhabdomyolysis are factors contributing the development of AKI.
Severely injured patients (ISS > 24) older than 18 years.
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Exclusion Criteria:
Patients \> 18 years of age with acute kidney injury were enroled into the study. Arterial levels of neutrophil gelatinase-associated lipocalin (NGAL), arterial lactate, interleukin-6 (IL-6), procalcitonin (PCT) and myoglobin were investigated in all patients.
Diagnostic Test: Neutrophil gelatinase-associated lipocalin (NGAL) · Diagnostic Test: Arterial lactate · Diagnostic Test: Interleukin-6 (IL-6) · Diagnostic Test: Procalcitonin (PCT) · Diagnostic Test: Myoglobin
Blood neutrophil gelatinase-associated lipocalin (NGAL) test was performed in all patients.
Arterial lactate level was assessed in all patients.
The level of interleukin-6 was assessed in all patients.
The level of procalcitonin (PCT) was assessed in all patients.
The level of myoglobin was assessed in all patients.
Acute Kidney Injury biomarker validity
The main goal of the study was to evaluate the validity of AKI biomarker neutrophil gelatinase-associated lipocalin in AKI prediction in severely injured patients with Injury Severity Score (ISS) \> 24.
Time frame: 36 months
Time-dependent role of insults
Secondary outcome measure was to determine the time-dependend role of insults associated directly with intensity of injury (tissue hypoxia, systemic inflammatory response and/or infection, rhabdomyolysis) in the pathopfysiology of AKI.
Time frame: 36 months
Ran from Jun 2013 to primary completion in Dec 2015, 30 months.
Of 349 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 30 months is above that.
Counting every sponsor, half of 364 studies reached it within 24 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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