NCT00513825

Brief Summary

Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents. Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the uniformly accepted prophylaxy) in preventing RCIN.But most studies have excluded patients with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or ejection fraction less than 30%. Therefore the aim of this study is to evaluate the efficacy of sodium bicarbonate solved in half saline compared with infusion of half saline in prevention of RCIN in these groups of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

Enrollment Period

11 months

First QC Date

August 8, 2007

Last Update Submit

November 23, 2008

Conditions

Contrast Induced Nephropathy

Keywords

Contrast NephropathySodium BicarbonatePrevention

Outcome Measures

Primary Outcomes (1)

  • development of contrast induced nephropathy defined as an absolute (> or = 0.5 mg/dl) or relative increase (> or = 25%) in serum creatinine at 48 hours after exposure to a contrast agent compared to baseline serum creatinine values.

    at 48 hours

Secondary Outcomes (4)

  • an absolute (> or = 0.5 mg/dl) or relative increase(> or= 25% ) in serum creatinine at day 5 after exposure to a contrast agent.

    at day 5

  • Urine PH after initial bolus

    within 6 hours after initial bolus

  • development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR) at 48 hours.

    at 48 hours

  • development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR)on day 5 .

    on day 5 post contrast

Study Arms (2)

1

ACTIVE COMPARATOR

1075 cc of 77 mEq/L solution of NaCl 0.45% , prepared by adding 75 cc of 77 mEq/L NaCl 0.45 % to 1000 cc of 77 mEq/L NaCl 0.45%

Drug: Sodium Bicarbonate

2

ACTIVE COMPARATOR

1075 cc fluid made by adding 75 cc of sodium bicarbonate solution 8.4% to 1000 cc of NaCl 0.45%.

Drug: Sodium Bicarbonate

Interventions

Sodium BicarbonateDRUG

IV solution of NaCl 0.45% (Arm 1) or IV 75 cc of sodium bicarbonate 8.4% solved in 1 liter of NaCl 0.45% (Arm 2) . Each fluid is infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.

12

Eligibility Criteria

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

You may qualify if:

  • individuals aged 18 years or older with serum creatinine levels of at least 1.5 mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery angiography.
  • Patients with a history of Pulmonary edema or
  • Patients with severe Heart Failure ( NYHA 3-4) or
  • Patients with ejection fraction of less than 30% on Echocardiography ( done in the previous month of admission) or
  • Patients with uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg )

You may not qualify if:

  • serum creatinine levels of more than 8 mg/dl
  • previous history of dialysis
  • GFR \< 20 ( as calculated with this formula: ((140-Age)(Weight(Kg)) / Serum Creatinine(mg/dl) Ă—72 ) , in females GFR was multiplied by 0.85 )
  • emergency catheterization
  • recent exposure to radiographic contrast agents (within previous two days of the study)
  • radiocontrast agent dosage needed more than 300 gr during the procedure
  • allergy to radiocontrast agent
  • pregnancy
  • administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
  • need for continuous hydration therapy (e.g. sepsis )
  • history of Multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran Heart Center

Tehran, Iran

Location

MeSH Terms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Ali Farahani Vasheghani, M.D.

    Tehran University of Medical Sciences, Tehran Heart Center

    STUDY DIRECTOR

  • Ebrahim Kassaian, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Akbar Fotuhi, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Mohammad Reza Khatami, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Mojtaba Salarifar, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Ebrahim Nematipur, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Ahmad Iaminisharif, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Saeid Sadeghian, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Ali mohammad Hajzeinali, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Mohammad Alidoosti, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Hamidreza Purhosseini,, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Ali Kazemisaeid, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Gholamreza Davoodi, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Alireza Amirzadegan, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Abbas Soleimani, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Sirus Darabian, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Kianush Hossein, M.D.

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Gelareh Sadigh, M.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Amir Hossein Razavi, M.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

August 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 26, 2008

Record last verified: 2008-11

Locations

IR(1)