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We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.
We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | hydration with normal saline |
|
| 2 | Experimental | hydration with sodium bicarbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium bicarbonate infusion | Other | short infusion of sodium bicarbonate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Contrast Induced nephropathy | 48 hours |
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Inclusion Criteria:
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
Exclusion Criteria:
Patients who fall under any of the following categories will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Fawaz Al Turki, MD | King Faisal Specialist Hospital & Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital & Research Center | Riyadh | 11211 | Saudi Arabia |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D052801 | Male Urogenital Diseases |