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| [ ...Back to search results ] | [ Print-friendly version ] |
| Correction of acidosis in chronic kidney disease (CKD) |
| Source of record | UK Trials |
| ISRCTN | ISRCTN17109689 |
| Date ISRCTN assigned | 18/01/2008 |
| Local reference number(s) | P/01/211 |
| Public title | Correction of acidosis in chronic kidney disease (CKD) |
| Scientific title | Effects on progression of renal failure and nutritional status by correction of metabolic acidosis in patients with non-dialysis dependent chronic kidney disease (CKD) |
| Acronym | N/A |
| Disease/condition/study domain | Chronic kidney disease |
| Study hypothesis | Experimental data suggest that acidosis induced excessive renal ammoniagenesis and activation of the complement cascade by the alternative pathway, lead to rapid progression of renal failure which can be attenuated by bicarbonate supplementation. Moreover, metabolic acidosis accelerates protein catabolism and causes malnutrition due to an induced negative nitrogen balance in patients with end-stage renal disease (ESRD). We propose that correction of acidosis will attenuate the progression of renal failure and will improve nutritional status in patients with non-dialysis dependent chronic kidney disease. |
| Design/methodology | Randomised prospective parallel group study of patients in stage 4 and 5 CKD |
| Research ethics review | The study is approved by the Local Research Ethics Committee from April 2002 to July 2006 (ref: P/01/211). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Age greater than 18 years old 2. CKD stage 4 and 5 3. Mild to moderate metabolic acidosis (serum bicarbonate less than 21 and greater than 16 mmol/L) on two consecutive measurements 4. Stable clinical condition |
| Participants - exclusion criteria | Patients with: 1. Malignant disease 2. Morbid obesity 3. Cognitive impairment 4. Chronic sepsis 5. Poorly controlled blood pressure (greater than 150/90 mmHg), despite use of four agents 6. Overt congestive heart failure |
| Patient information material | |
| Anticipated start date | 30/04/2002 |
| Anticipated end date | 30/07/2006 |
| Status of trial | Completed |
| Target number of participants | 134 |
| Interventions | Sodium bicarbonate versus no treatment. Duration of treatment: 2 years Method of intake: oral Frequency of treatment: daily 600 mg three times a day to be titrated up by 600 mg till serum biocarbonate level of greater than 21 mmol/l were achieved Duration of follow up: 2 years |
| Primary outcome measure(s) | The primary end points were number of patients reaching ESRD and rate of decline of estimated glomerular filtration rate (eGFR) by Cockroft-Gault equation and creatinine clearance (Cr Cl) (24 hours urine sample). Primary end points are measured every three months. |
| Secondary outcome measure(s) | Nutritional parameters assessed by: 1. Dietary protein intake 2. Protein catabolic rate (PCR) 3. Serum albumin 4. Mid-arm muscle circumference (MAMC) Secondary end points measured every six months. |
| Sources of funding | Barts and the London NHS Trust (UK) |
| Sponsor name | Barts and the London NHS Trust (UK) |
| Sponsor details | c/o Gerry Leanord Research and Development Directorate Whitechapel London United Kingdom E1 1BB |
| Sponsor website | http://www.bartsandthelondon.org.uk/ |
| Contact name | Prof Muhammad Magdi Yaqoob |
| Contact details | Renal Unit Royal London Hospital Whitechapel London United Kingdom E1 1BB |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17109689 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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