NCT00424320

Brief Summary

The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed
Last Updated

January 19, 2007

Status Verified

January 1, 2007

First QC Date

January 18, 2007

Last Update Submit

January 18, 2007

Conditions

Acute Kidney Failure

Keywords

Acute kidney failureContrast-induced nephropathyNon-ionic contrast mediaIonic contrast mediaIopamidolPercutaneous coronary interventionCoronariography

Outcome Measures

Primary Outcomes (1)

  • Contrast-induced nephropathy

Secondary Outcomes (1)

  • Hemodialysis

Interventions

Sodium bicarbonateDRUG

Eligibility Criteria

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

You may qualify if:

  • Age over 18 years old
  • Indication for coronariography and/or percutaneous coronary intervention
  • Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial
  • A MEHRAN contrast-induced nephropathy score of six or more

You may not qualify if:

  • Patients with chronic kidney failure requiring any kind of dialysis
  • Patients unable to complete follow-up
  • Multiple myeloma
  • Exposure to contrast 48 hours prior to study
  • Pregnancy
  • Patients unable to give consent
  • Already receiving sodium bicarbonate solutions
  • Receiving contrast media other than non-ionic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ABC Medical Center

Mexico City, Mexico City (d.f.), 01120, Mexico

RECRUITING

Ignacio Chávez National Institute of Cardiology

Mexico City, Mexico City (d.f:), 14080, Mexico

RECRUITING

Related Publications (9)

  • Bagshaw SM, Ghali WA. Acetylcysteine for prevention of contrast-induced nephropathy after intravascular angiography: a systematic review and meta-analysis. BMC Med. 2004 Oct 22;2:38. doi: 10.1186/1741-7015-2-38.

    PMID: 15500690BACKGROUND

  • Itoh Y, Yano T, Sendo T, Oishi R. Clinical and experimental evidence for prevention of acute renal failure induced by radiographic contrast media. J Pharmacol Sci. 2005 Apr;97(4):473-88. doi: 10.1254/jphs.crj05002x. Epub 2005 Apr 9.

    PMID: 15821342BACKGROUND

  • Aspelin P. Nephrotoxicity and the role of contrast media. Radiat Med. 2004 Nov-Dec;22(6):377-8. No abstract available.

    PMID: 15648451BACKGROUND

  • Mueller C, Seidensticker P, Buettner HJ, Perruchoud AP, Staub D, Christ A, Buerkle G. Incidence of contrast nephropathy in patients receiving comprehensive intravenous and oral hydration. Swiss Med Wkly. 2005 May 14;135(19-20):286-90. doi: 10.4414/smw.2005.10938.

    PMID: 15986266BACKGROUND

  • Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.

    PMID: 15911862BACKGROUND

  • Cavusoglu E, Chhabra S, Marmur JD, Kini A, Sharma SK. The prevention of contrast-induced nephropathy in patients undergoing percutaneous coronary intervention. Minerva Cardioangiol. 2004 Oct;52(5):419-32.

    PMID: 15514576BACKGROUND

  • Rezkalla SH. Contrast nephropathy. Clin Med Res. 2003 Oct;1(4):301-4. doi: 10.3121/cmr.1.4.301.

    PMID: 15931323BACKGROUND

  • Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.

    PMID: 15150204BACKGROUND

  • Briguori C, Airoldi F, Morici N, Colombo A. New pharmacological protocols to prevent or reduce contrast media nephropathy. Minerva Cardioangiol. 2005 Feb;53(1):49-58.

    PMID: 15788979BACKGROUND

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Emma Miranda Malpica, PhD

    Ignacio Chávez National Institute of Cardiology

    PRINCIPAL INVESTIGATOR

  • Marco A Martínez Ríos, MD, FACC

    Ignacio Chávez National Institute of Cardiology

    STUDY DIRECTOR

  • Jorge Gaspar Hernández, MD

    Ignacio Chávez National Institute of Cardiology

    STUDY CHAIR

Central Study Contacts

Emma Miranda Malpica, PhD

CONTACT

52+55+55499120malpicae@yahoo.com.mx

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 19, 2007

Study Start

October 1, 2006

Study Completion

January 1, 2007

Last Updated

January 19, 2007

Record last verified: 2007-01

Locations

ME(2)