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| Name | Class |
|---|---|
| Satellite Healthcare | OTHER |
| Triax Pharmaceuticals | UNKNOWN |
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This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minocycline | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minocycline | Drug | given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of Post-operative Acute Kidney Injury | Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively | up to 5 days post cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Hospital Days | 30 days post-operative | |
| On Vent >48 Hours | on ventilator > 48 hours | 30 days post op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek M El-Achkar, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | St Louis | Missouri | 63103 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25348221 | Result | Golestaneh L, Lindsey K, Malhotra P, Kargoli F, Farkas E, Barner H, Qazi R, Schmidt A, Rauchman M, Al-Aly Z, Johnson R, Martin K, Dagher P, Friedman A, El-Achkar TM. Acute kidney injury after cardiac surgery: is minocycline protective? J Nephrol. 2015 Apr;28(2):193-9. doi: 10.1007/s40620-014-0152-2. Epub 2014 Oct 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Minocycline | minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses |
| FG001 | Placebo | placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Minocycline | minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses |
| BG001 | Placebo | placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Development of Post-operative Acute Kidney Injury | Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively | Posted | Number | participants meeting primary oputcome | up to 5 days post cardiac surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Minocycline | minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tarek El-Achkar | St Louis University | 317 278 6822 | telachka@iu.edu |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D014947 | Wounds and Injuries |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| placebo | Drug | placebo will be given for at least 4 doses pre-op to a maximum of 14 doses |
|
| Infections Post Operative |
| 30 days post operative |
| Stroke Post Operative | 30 days post op |
| Re-operation | 30 days post-operative |
| The Bronx |
| New York |
| 10467 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| kidney function | Estimated GFR (MDRD) | Mean | Standard Deviation | ml/min |
|
|
| Secondary | Post Operative Hospital Days | Posted | Mean | Standard Error | days | 30 days post-operative |
|
|
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| Secondary | On Vent >48 Hours | on ventilator > 48 hours | Posted | Number | percentage of participant per group | 30 days post op |
|
|
|
| Secondary | Infections Post Operative | Posted | Count of Participants | Participants | 30 days post operative |
|
|
|
| Secondary | Stroke Post Operative | Posted | Count of Participants | Participants | 30 days post op |
|
|
|
| Secondary | Re-operation | Posted | Count of Participants | Participants | 30 days post-operative |
|
|
|
| 4 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses | 3 | 19 | 0 | 19 |
| Death | Cardiac disorders | Death within 30 days post-op |
|
| Reop | Cardiac disorders | Need for reoperation within 30 days |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |