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

NCT01640119 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 728

Last updated 2014-09-19

No results posted yet for this study

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.

Conditions

  • Metabolic Acidosis

Interventions

DIETARY_SUPPLEMENT

Bicarbonate

bicarbonate administration

Sponsors & Collaborators

  • Azienda Sanitaria ASL Avellino 2

    lead OTHER

Principal Investigators

  • Biagio Di Iorio, MD, PhD · Azienda Sanitaria ASL Avellino 2

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-12-31
Completion
2017-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640119 on ClinicalTrials.gov