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| Name | Class |
|---|---|
| Cairo University | OTHER |
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The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.
The study will investigate the possible nephroprotective effect of curcumin when added to patients infected by MDR Gram-negative bacteria and require intravenous colistin therapy, curcumin will be given concurrently with colistin and discontinued at the same time as Colistin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours. |
|
| Group 2 | Active Comparator | patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours and curcumin will be administered as orally or through nasogastric tube at a dose of 2 capsules every 6 hours (1 gm/6 hour) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistin | Drug | added for infection with multi drug resistant bacteria |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of acute kidney injury | colistin induced nephrotoxicity (CIN) is defined as increase of serum creatinine by 0.3 mg/dL 48 hours after colistin administration | Baseline to hospital discharge, an average of 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of acute tubular necrosis (ATN) | will be evaluated by fractional excreted sodium (FENa) | Baseline to hospital discharge, an average of 14 days. |
| The difference between the levels of urinary NGAL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa M. Hammad | Contact | 01000675555 | alaa.hammad.ph@o6u.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nirmeen A. Sabry | Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University | Principal Investigator |
| Maggie M. Abbassi | Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Recruiting | Cairo | 1133 | Egypt |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003091 | Colistin |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Curcumin |
| Drug |
added for the possible nephroprotective effect |
|
| Baseline to hospital discharge, an average of 14 days. |
| Mortality rate | Baseline to 30 days post discharge |
| Total length of ICU and hospital stays. | Baseline to hospital discharge, an average of 14 days. |
| Rania El-Husseiny | Professor of Critical Care Medicine, Faculty of Medicine Cairo University | Principal Investigator |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D055666 |
| Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |