NCT00531765

Brief Summary

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

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

June 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

2.9 years

First QC Date

September 17, 2007

Last Update Submit

July 24, 2010

Conditions

Contrast Induced Nephropathy

Keywords

contrast-induced-nephropathy,cardiac cathcreatininecontrastnephropathy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Contrast Induced nephropathy

    48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

hydration with normal saline

Other: sodium bicarbonate infusion

2

EXPERIMENTAL

hydration with sodium bicarbonate

Other: sodium bicarbonate infusion

Interventions

sodium bicarbonate infusionOTHER

short infusion of sodium bicarbonate

12

Eligibility Criteria

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

You may qualify if:

  • All adult patients (18 years and above) who are scheduled for cardiac catechization and have abnormal but stable renal function will be eligible for enrollment. Abnormal renal function is defined as a creatinine level exceeding the normal range (more than 115 or 96 um/L in males and females, respectively, in KFSH\&RC laboratories) or eGFR less than 60 ml/min

You may not qualify if:

  • Patients who fall under any of the following categories will be excluded:
  • Acute renal failure
  • Cardiogenic shock
  • Emergency cardiac catheterization
  • Preexisting peritoneal or hemodialysis
  • Pregnancy
  • Recent exposure to contrast agent within the last 3 days
  • Allergy to contrast or any of the above treatment
  • Renal transplant,
  • Patients who received dopamine, mannitol, theophyllin or other medications known to affect renal function within one week from cardiac cath
  • Pulmonary edema / congestive heart failure
  • Use of N-acetylcystein
  • Patents on NSAIDS who can not stop using them for 48 hrs before and 48 hrs after procedure (except Aspirin).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Fawaz Al Turki, MD

    King Faisal Specialist Hospital & Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2007

First Posted

September 19, 2007

Study Start

June 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

SA(1)