NCT00634491

Brief Summary

The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
Last Updated

March 13, 2008

Status Verified

March 1, 2008

Enrollment Period

5 months

First QC Date

February 14, 2008

Last Update Submit

March 4, 2008

Conditions

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Increased base line creatinine at least 25%

    24 hr later

Study Arms (3)

1

ACTIVE COMPARATOR

150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography

Drug: sodium bicarbonate

2

ACTIVE COMPARATOR

Acetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography

Drug: Acetazolamide

3

ACTIVE COMPARATOR

normal salin 1cc/kg/hr before and after angiography

Drug: normal salin

Interventions

sodium bicarbonateDRUG

150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography

Also known as: no other name
1
AcetazolamideDRUG

Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography

Also known as: Diamox
2
normal salinDRUG

1 cc/kg/hr 6 hour before and after angiography

Also known as: no other name
3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient that underwent coronary angiography

You may not qualify if:

  • serum Cr. more than 3 mg/dl
  • electrolyte and acid-base imbalance
  • pulmonary edema
  • allergy to Acetazolamide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fars Heart Foundation , Kowsar hospital

Shiraz, Iran

Location

Related Publications (1)

  • Assadi F. Acetazolamide for prevention of contrast-induced nephropathy: a new use for an old drug. Pediatr Cardiol. 2006 Mar-Apr;27(2):238-42. doi: 10.1007/s00246-005-1132-z.

    PMID: 16391986RESULT

MeSH Terms

Interventions

Sodium BicarbonateAcetazolamide

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Maryam Pakfetrat, MD

    Shiraz nephro-urology research center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

March 13, 2008

Study Start

September 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 13, 2008

Record last verified: 2008-03

Locations

IR(1)