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Status unknownNCT00716001Updated Jul 15, 2008

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

A Phase 4 interventional study of N-acetylcysteine in Chronic Renal Failure, sponsored by Osaka General Medical Center. Status unknown. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2008-07-15.

Sponsored by Osaka General Medical Center · Phase 4 and Interventional

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Renal Failure

Keywords

  • patients with chronic renal failure undergoing elective percutaneous coronary intervention
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

Browse Renal Insufficiency studies →

Lead sponsor

Osaka General Medical Center is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Study arms

  • Active comparator
    NAC

    Drug: N-acetylcysteine

  • Placebo comparator
    nonNAC

    Drug: N-acetylcysteine

Interventions

  • DrugN-acetylcysteine
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00716001
Lead sponsor
Osaka General Medical Center
First posted
Jul 15, 2008
Start date
Jul 2008
Primary completion
Jun 2009 (estimated)
Last update
Jul 15, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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