MedDataX Logo

Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure

NCT ID: NCT00716001

Last Updated: 2008-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Renal Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

patients with chronic renal failure undergoing elective percutaneous coronary intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NAC

Group Type ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type DRUG

nonNAC

Group Type PLACEBO_COMPARATOR

N-acetylcysteine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-acetylcysteine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with chronic renal failure(serum creatinine \>1.1mg/dl) undergoing elective percutaneous coronary intervention

Exclusion Criteria

* administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
* pregnancy
* congestive heart failure
* allergy to sodium bicarbonate and/or N-acetylcysteine
* hemodialysis
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Osaka General Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Osaka General Medical Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OPTSB

Identifier Type: -

Identifier Source: org_study_id