- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07668141
Colistin Nephrotoxicity and Role of Alpha Lipoic Acid
Colistin Nephrotoxicity in Hospitalized Patients: The Role of Biomarkers in Guiding the Preventive Strategies
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
According to World Health Organization (WHO), multidrug resistant (MDR) pathogens (e.g. Extended-spectrum beta-lactamases (ESBL), Carbapenem Resistant Enterobacteriaceae (CRE)) are one of the major public threats that yearly cause several million deaths globally. In 2019, Egypt recorded 56,600 deaths linked to antimicrobial resistance (AMR), ranking 58th out of 204 countries for age-standardized mortality rates related to AMR. Regarding the North Africa and Middle East region, Egypt has the second highest mortality rate among 21 countries. The deaths from AMR in Egypt surpass those from diabetes, kidney diseases, transport injuries, chronic respiratory diseases, respiratory infections, tuberculosis, and neurological disorders. In 2021, WHO published the list of antibiotic-resistant pathogens especially the critical group of MDR bacteria includes Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacteriaceae, which cause severe infections in hospitalized patients. The resistance rate of carbapenem-resistant gram-negative bacteria (CR-GNB) is increasing over time. According to data from the chain antimicrobial resistance surveillance system, the resistance rate of carbapenem-resistant Klebsiella pneumoniae increased from 4.9% to 10.9% from 2013 to 2020. The resistance rates of carbapenem-resistant Acinetobacter baumannii and Enterobacteriaceae were 53.7% and 18.3%, respectively, in 2020.
Colistin is a polymyxin antibiotic first developed in 1947, fell out of favor due to its nephrotoxicity. With the rise of extensively drug-resistant Gram-negative bacteria, colistin has re-emerged as a last-resort treatment. However, its nephrotoxicity is considered as the main obstacle for using this valuable antibiotic. Colistin-induced nephrotoxicity has been reported in about 20-60% of treated patients. The mechanism of renal toxicity is through increased permeability of the renal tubular epithelium, increasing renal oxidative stress leading to cellular lysis and acute tubular necrosis. Nephrotoxicity incidence is influenced by many risk factors including dosage, and patient-related characteristics such as age, preexisting renal disease, diabetes, hypoalbuminemia, and other concomitant nephrotoxic compounds exposure.
AKI is usually diagnozed based on SCr and urine output. However, these markers are not specific and sensitive to GFR due to extra-renal factors, such as nutrition status, age, and muscle mass and fluid resuscitation. Serum creatinine is nonspecific to structural injury and has a nonlinear relationship with GFR, indicating that vast changes in GFR only signify a slight change in SCr. the changes in creatinine level lag behind the decreases in the GFR and can take up to 24-36 h to show a significant increase after obvious renal insult. Recognizing pharmacological interventions used to prevent or attenuate colistin-induced nephrotoxicity has gained special interest among healthcare professionals in recent years. Different clinical and preclinical studies were conducted to investigate the nephro-protective effect of some antioxidants e.g. melatonin, N-acetyl cysteine (NAC) and alpha lipoic acid (ALA) to prevent colistin nephrotoxicity. For example, ALA administration could reverse the effects of colistin-induced nephrotoxicity, owing to its antioxidant and anti-apoptotic effect as showed in a preclinical study on 2021.
Till now, there is no any published human study to evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity. In addition the paucity of studies that early predict colistin-induced nephrotoxicity especially in Egypt which has a growing need for colistin therapy as it has the higher rates of antimicrobial resistance associated mortality in the North Africa and Middle East region.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Eman Magy Elsayed Elyamany, Assistant lecturer
- Telefonní číslo: +201121051356
- E-mail: Iman.elyamany@pharm.capu.edu.eg
Studijní záloha kontaktů
- Jméno: Mahmoud Ibrahim Mostafa, Lecturer
- Telefonní číslo: +201006605563
- E-mail: mahmoud.ibrahim@pharm.capu.edu.eg
Studijní místa
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Giza, Egypt
- 6th October Hospital-Dokki-General Authority for Health Insurance Organization
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Kontakt:
- Mohamed Taher Mohy Eldien, Vascular surgery consultant
- Telefonní číslo: +201272228188
- E-mail: mtm84mohy@gmail.com
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Giza, Egypt
- Al-Haram Hospital
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Kontakt:
- Ghada Abdelwahab Ali, Nephrology consultant
- Telefonní číslo: +201022610334
- E-mail: Ghadaabdeleahab@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adult patients who receive intravenous colistin and had positive cultures of multidrug resistant gram negative bacteria.
- Patients who receive colistin for at least 3 days during their treatment.
Exclusion Criteria:
- Patients who receive inhaled colistin.
- Patients who had AKI at baseline
- chronic kidney disease patients on regular hemodialysis.
- Renal transplant patients
- Concurrent use of other nephrotoxic drugs e.g. vancomycin, gentamicin, amikacin and amphotericin B.
- Concurrent use of other antioxidants e.g. vitamin C, vitamin E and N-acetyl cysteine.
- Patients are not willing to participate in the study.
- Patients with any missed doses of colistin and or alpha-lipoic acid.
- Patients with incomplete medical data
- Pregnant or breastfeeding women.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Control group
this group receives only intravenous colistin therapy
|
|
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Aktivní komparátor: alpha lipoic acid group
this group receives oral alpha lipoic acid in addition to intravenous colistin therapy
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Oral alpha-lipoic acid will be administered at the start of colistin therapy till the end of the colistin course by a dose of 600 mg every 8 hours to be taken 30 min before meals in the intervention group.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in urinary kidney injury molecule-1 (KIM-1)
Časové okno: Baseline to Day 5
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Urinary KIM-1 will be measured at baseline and on Day 5 of treatment in patients receiving colistin alone or colistin plus alpha-lipoic acid.
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Baseline to Day 5
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time to Development of Acute Kidney Injury
Časové okno: From randomization until the first occurrence of acute kidney injury, hospital discharge, death from any cause, or colistin discontinuation, whichever occurs first, assessed up to 30 days.
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Time from randomization to the first documented occurrence of acute kidney injury during colistin therapy in the control group and the intervention group.
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From randomization until the first occurrence of acute kidney injury, hospital discharge, death from any cause, or colistin discontinuation, whichever occurs first, assessed up to 30 days.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Eman Magdy Elsayed Elyamany, Assistant lecturer, Faculty of pharmacy-Helwan university
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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