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Bolus-pCINC Study

Bolus Administration of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy after Emergency Percutaneous Coronary Intervention. - Bolus-pCINC Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051210170
Enrollment
260
Registered
2022-02-07
Start date
2022-02-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial inferction (ST-elevation myocardial infarction, non-ST-segment elevation myocard)

Interventions

Bolus administration of sodium bicarbonate immediately before contrast medium administration

Sponsors

Watanabe Makoto
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 20 years old and over 2 Patients heading directly to the cardiac catheterization laboratory from the emergency outpatient department or patients with in-hospital onset 3 Patients with suspected acute myocardial infarction based on changes in electrocardiogram, elevation of myocardial enzyme, or echocardiography 4 Patients who consented to patient or legal acceptable representative in the study

Exclusion criteria

Exclusion criteria: 1 Patients with shock or cardiopulmonary arrest upon arrival at the emergency department 2 Patients with impaired consciousness, orthopnoea, or needing tracheal intubation and non-invasive positive pressure ventilation (NIPPV) upon arrival at emergency department 3 Patients who received oral or intravenous sodium bicarbonate before CAG was performed 4 Patients who are allergic to contrast agents at the time of registration 5 Patients who undergoing dialysis 6 Patients who uncontrolled hyperthyroidism or hypothyroidism 7 Patients who received contrast media within 7 days of CAG or PCI 8 Patients who did not undergo PCI as the result of CAG 9 Patients who did not diagnosed with acute myocardial infarction

Design outcomes

Primary

MeasureTime frame
CIN occur within 48 +- 12 hours CIN is defined by as follows: 1: SCr increased by more than 0.5 mg/dL from the time of enrollment 2: SCr increased by more than 25% from the time of enrollment

Secondary

MeasureTime frame
1 Acute renal dysfunction (SCr increase of >=1.5 times or >=0.3 mg/dL based on SCr at enrollment) occur within 48+-12 hours 2 CIN(SCr increased by 0.5 mg / dL or more or 25% or more based on SCr at enrollment) occur within 72 +- 12 hours 3 SCr increase after Catheterization / treatment at 24 +- 12 hours, at 48 +- 12 hours, at 72 +- 12 hours

Contacts

Public ContactMakoto Watanabe

Nara Medical University Hospital

watamkt@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026