colistin-induced nephrotoxicity in patients admitted to the Intensive Care Unit. ICD-10 (http://apps.who.int/classifications/icd10/browse/2010/en)
Conditions
Interventions
Intervention 1: Intervention group: Hydroalcoholic extract of pomegranate peel during the administration of cysteine for a duration of ten days. Intervention 2: Control group: The placebo group will r
Sponsors
Mashhad University of Medical Sciences
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years Ability to receive medication orally or via gavage (based on ICU nurse assessment) No concurrent use of medications with potential for drug interaction with pomegranate, including:Fluvoxamine, Nateglinide, Glipizide, RepaglinideAnxiolytics, Warfarin, SildenafilCarbamazepine, Alprazolam, Diazepam, or other benzodiazepines No unnecessary concurrent use of nephrotoxic drugs (except for specific antimicrobials like Vancomycin, aminoglycosides, and Amphotericin, whose use will be recorded and included in statistical analysis) Absence of severe gastrointestinal disorders that would prevent oral or gavage absorption of the supplement (such as intestinal obstruction, active bleeding, severe malabsorption, uncontrollable nausea and vomiting) Completion of the written informed consent form No concurrent consumption of juices such as grapefruit or orange due to the possibility of interference with metabolic enzymes
Exclusion criteria
Exclusion criteria: GFR less than 60 mL/min at the start of Colistin therapy Any underlying renal disorder including:Glomerulonephritis, polycystic kidney disease, kidney stones, interstitial nephritis, renal artery stenosis, kidney cancer Underlying diseases affecting kidney function such as diabetes mellitus and hypertension, kidney transplant History of Acute Kidney Injury (AKI) based on medical record Severe gastrointestinal disorders (as per Inclusion Criteria item 5) Pregnant or breastfeeding women Known history of hypersensitivity to pomegranate or occurrence of severe allergic reactions during the study Patient withdrawal from continued participation Inability to administer the supplement orally or via gavage (due to non-compliance or clinical contraindication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Measurable Outcomes: Incidence of Acute Kidney Injury (AKI): Based on the AKIN/KDIGO criteria, the occurrence of AKI will be assessed by either an increase of at least 0.3 mg/dL in serum creatinine within 48 hours or a 50% rise in serum creatinine over the same period. Analysis of AKI Stage Distribution: The distribution of AKI stages, according to the AKIN/KDIGO classification, will be compared between the pomegranate-treated group and the placebo group. Estimation of Glomerular Filtration Rate (GFR): In cases of AKI, GFR will be calculated using the kinetic estimated GFR (keGFR) formula. Comparison of Renal Function Indicators: Serum creatinine and blood urea nitrogen (BUN) levels will be compared between the intervention (pomegranate) and control (placebo) groups. Timepoint: Primary Outcome: Serum creatinine and BUN levels, measured every other day (three times per week), and assessment of the incidence of acute kidney injury (AKI) based on AKIN/KDIGO criteria.Secondary Outcomes: Changes in APACHE and SOFA scores, WBC and differential count, CRP, and procalcitonin levels at the end of the first week. Daily monitoring of vital signs. Method of measurement: The intervention period in this study is designed for an average of 10 days, during which clinical and safety follow-ups will also be conducted. Throughout this period, vital signs will be monitored daily, and functional and inflammatory markers, including APACHE and SOFA scores, WBC and differential counts, CRP, and procalcitonin levels, will be recorded at the beginning and end of the first week. BUN and creatinine levels will be checked every 72 hours, at the end of the intervention and 72 hours post-intervention. If any new cultures are performed, the associated data will also be recorded.Patients will be excluded from the study if they develop a severe complication or hypersensitivity reaction to pomegranate, or if they wish to discontinue participation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response Assessment:Changes in SOFA and APACHE scores, vital signs, and serum levels of CRP and procalcitonin will be analyzed in both study groups to determine the extent of clinical improvement in patients. Timepoint: Monitoring will include changes in APACHE and SOFA scores, white blood cell count with differential (WBC diff), C-reactive protein (CRP), and procalcitonin levels at the end of one week, along with daily vital signs assessment. Method of measurement: Monitoring will include changes in APACHE and SOFA scores, white blood cell count with differential (WBC diff), C-reactive protein (CRP), and procalcitonin levels at the end of one week, along with daily vital signs assessment, performed via scoring and blood tests. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahboobeh Ghasemzadeh Rahbardar
Mashhad University of Medical Sciences
Outcome results
None listed