Clinical Trial: Correction of Metabolic Acidosis in End Stage Renal Disease (ESRD)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Controlled, Randomized, Multicentric Study: Correction of Metabolic Acidosis With Use of Bicarbonate in Chronic Renal Insufficiency (CKD3b-4)

Brief Summary:

The investigators want to evaluate whether an original action based on the administration of alkali (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce mortality due to cardiovascular events.

Methods: This is a proposal of Multicentric, prospective, cohort, randomized, open-label and controlled study.

The investigators will Randomize 728 patients with Chronic Kidney Disease(CKD) stage 3b (CKD-3b) and CKD stage 4: 364 of these patients will be included in the study group called Bicarbonate Group (Bic), in which levels of bicarbonate should be kept > 24 mEq/l; the other 364 patients will included in the Usual Treatment Group (no-Bic).

Results: The aim of the Research Protocol is to demonstrate if that the optimal correction of uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing agent, e.g. sodium citrate) reduces renal and cardiovascular mortality.

Conclusions. In conclusion the Work Group of the Conservative Therapy for Chronic Renal Insufficiency proposes this cohort, randomized, controlled, prospective, multicentric study to evaluate the effects of correction of acidosis on the progression of the kidney disease considered as renal death in End-Stage Renal Disease (ESRD) patients.


Detailed Summary:

Rationale:

Chronic Kidney Disease (CKD) is associated with a high incidence of morbility and mortality.

In this regard, the National Health and Nutrition Examination Survey (NANHES) shows that 19% of the uremic population presents metabolic acidosis (CKD stage 4). This high prevalence and the low costs of the correction by bicarbonate pave the way for a potential and interesting research activity.

In fact, a Cochrane Collaboration review reports that there is no evidence for correction of acidosis by sodium bicarbonate in pre-End-Stage Renal Disease) (ESRD) patients, and concludes that randomized controlled trials (RCTs) are necessary to evaluate the benefits and harms of correcting metabolic acidosis in pre-ESRD patients.

During the same year, 2009, another RCT appears in the scientific literature showing that the administration of sodium bicarbonate, and the consequent correction of acidosis, slows the progression of CKD and improves the nutritional status in ESRD patients stages 4-5. This study was randomized, prospective, open-label, monocentric, and was conducted on 134 patients.

It is well known that acidosis stimulates proteic catabolism, accelerates branched-chain amino acid oxidation and reduces the synthesis of visceral proteins. The beneficial effects of bicarbonate in experimental models in rats and the effects of correcting acidosis on the nutritional status are also known.

Less information is available on the possibility that correcting acidosis in pre-ESRD patients slows renal death and improves outcomes also in the future, on dialysis.

The above cited study of B
Sponsor: Azienda Sanitaria ASL Avellino 2

Current Primary Outcome: doubling of creatinine [ Time Frame: 36 months ]

the primary outcome will be reached when the seric creatinine level (mg/dl) will double compared to the basal value.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • all-cause death [ Time Frame: 36 month ]
    all-cause death of patients
  • start of renal replacement therapy [ Time Frame: 36 month ]
    start of dialysis (peritoneal dialysis or hemodialysis)


Original Secondary Outcome: Same as current

Information By: Azienda Sanitaria ASL Avellino 2

Dates:
Date Received: June 28, 2012
Date Started: July 2014
Date Completion: December 2017
Last Updated: September 17, 2014
Last Verified: September 2014