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Aldosterone antagonists for people with chronic kidney disease requiring dialysis

ABSTRACT: Abstract This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: This review aims to assess the benefits and harms of aldosterone antagonists, both non‐selective (spironolactone) and selective (eplerenone), in comparison to placebo or no intervention or standard care in people with ESKD requiring haemodialysis or peritoneal dialysis.

SUBMITTER: Hasegawa T

PROVIDER: S-EPMC6513429 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Interventions: All eligible participants will receive an imunochemical faecal occult blood test (IFOBT) kit (EIKEN brand) containing the test and instructions, with additional explanation provided by study staff, as required. A sample is then collected from two separate bowel motions. All samples will be self-collected. All completed kits will be sent and processed in a designated central laboratory and analysed according to the company’s standardised specifications. The results of this test can be positive, negative or inconclusive. All results will be sent via mail to the corresponding treating physicians, the participants and the research assistants at the Centre for Kidney Research. The screen is considered positive when one of the samples contains at least 50ng/ml of haemoglobin. Negative results are not followed up in the study but these patients are advised to continue with annual screening with their health practitioner. If the results are inconclusive, the participants will be contacted by phone and asked to repeat the test. Only participants with positive IFOBT findings will be referred for a diagnostic colonoscopy at a designated colonoscopic service. Study staff will track participants with positive IFOBT results and will ensure the referral process is scheduled effectively and efficiently for a colonoscopy. The participants will not be required to pay for the IFOBT kit or the diagnostic colonoscopy. Other clinical significant pathologies such as polyps, adenomas, vascular lesions will be documented and recorded. Wherever possible, they will be resected and sent for pathology. Depending upon the stage of initial diagnosis, further treatment may be required for participants with malignant polyps and cancers. All cancer diagnoses, including stage, histologica Primary outcome(s): Prevalence of a positive screening result (defined as positive IFOBT with at least one of the two stool samples containing at least 50ng/ml of haemoglobin) in people with chronic kidney disease in stages 3-5, dialysis and kidney transplant populations using the immunochemical faecal occult blood test. [Five years];Prevalence of colorectal cancer as determined with diagnostic colonoscopy, in people with chronic kidney disease in stages 3-5, dialysis and kidney transplant populations.[Five years];Test performance characteristics of immunochemical faecal occult blood screening, including: test specificity, positive predictive values and negative predictive value for colorectal cancers. [Five years] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

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Aldosterone antagonists for people with chronic kidney disease requiring dialysis

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