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Septic acute kidney injury is a condition associated with highly related to inflammatory molecules. Prebiotics and probiotics have shown to improve inflammatory cascade in animal model; In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.
Acute kidney injury is most commonly caused by sepsis, where endotoxemia and an expanding inflammatory reaction play a key role in its pathogenesis, when this condition is present it is highly related to poor clinical outcomes and higher mortality rates. There is no current specific treatment, and the therapeutic approach is more orientated to complication management. In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics. Intervention patients | Experimental | This patients will receive 2 doses of oral probiotics a day, for seven days |
|
| Placebo group | Placebo Comparator | This patients will receive 2 doses of oral placebo a day, for seven days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Biological | Administration of oral probiotics with 2 doses a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine | Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Number of defunctions among the subjects | 7 days |
| Renal replacement therapy | Number of participants that initiate renal replacement therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCG | Recruiting | Guadalajara | Jalisco | 44240 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23727171 | Background | Lameire NH, Bagga A, Cruz D, De Maeseneer J, Endre Z, Kellum JA, Liu KD, Mehta RL, Pannu N, Van Biesen W, Vanholder R. Acute kidney injury: an increasing global concern. Lancet. 2013 Jul 13;382(9887):170-9. doi: 10.1016/S0140-6736(13)60647-9. Epub 2013 May 31. | |
| 25229340 | Background | Siew ED, Davenport A. The growth of acute kidney injury: a rising tide or just closer attention to detail? Kidney Int. 2015 Jan;87(1):46-61. doi: 10.1038/ki.2014.293. Epub 2014 Sep 17. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 4, 2022 | |
| Unrelease | Dec 5, 2022 | |
| Release | Dec 5, 2022 | |
| Reset | Oct 5, 2023 | |
| Release | Oct 8, 2023 | |
| Reset | Mar 28, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 4, 2022 | Dec 5, 2022 | |||
| Dec 5, 2022 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D018805 | Sepsis |
| D012769 | Shock |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Double blind randomized controlled trial
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| Placebo | Other | Administration of oral placebo with 2 doses a day |
|
| 7 days |
| Final creatinine | Last recorded serum creatinine concentration | 7 days |
| Urinary output (final) | Quantification of urinary output in ml/Kg/hour | 7 days |
| Shock days | Use of vasopressor therapy during hospitalization | 7 days |
| Recuperation of basal creatinine | Serum creatinine reduction to 25% from basal creatinine | 7 days |
| Length of hospitalization | Days of hospitalization | 7 days |
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| 37724527 | Derived | Chavez-Iniguez JS, Ibarra-Estrada M, Gallardo-Gonzalez AM, Cisneros-Hernandez A, Claure-Del Granado R, Chavez-Alonso G, Hernandez-Barajas EM, Romero-Munoz AC, Ramos-Avellaneda F, Prieto-Magallanes ML, Plascencia-Cruz M, Tanaka-Gutierrez JA, Perez-Hernandez C, Navarro-Blackaller G, Medina-Gonzalez R, Alcantar-Vallin L, Renoirte-Lopez K, Garcia-Garcia G. Probiotics in septic acute kidney injury, a double blind, randomized control trial. Ren Fail. 2023;45(2):2260003. doi: 10.1080/0886022X.2023.2260003. Epub 2023 Sep 19. |
| Oct 5, 2023 |
| Oct 8, 2023 | Mar 28, 2024 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |