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Prospective observational study to ascertain changes in lung lung distensibility during protamine (drug) administration to reverse heparin (coagulant) and correlation with echo based right ventricular function

Prospective observational study to ascertain changes in lung compliance during protamine administration to reverse heparin and correlation withecho based right ventricular function

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/053376
Enrollment
50
Registered
2023-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: I059- Rheumatic mitral valve disease, unspecified

Interventions

None listed

Sponsors

DR Prabhat Tewari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age â?? From 18 Years To 60 Years 2 Gender â?? Both 3 Details â?? Patients 18-60 years old, undergoing sole mitral valve replacement, on cardiopulmonary bypass.

Exclusion criteria

Exclusion criteria: • Patients with severe Pre-op Pulmonary artery hypertension (RVSP >60 mmHg) • Known case of Chronic obstructive pulmonary disease (COPD) and other known pulmonary disease • Patients with h/o Balloon mitral valvotomy (BMV) or Closed mitral valvotomy (CMV) • Patients with signs of heart failure • Patients in atrial fibrillation, after weaning from Cardiopulmonary bypass • Diabetic patients on insulin therapy • Any skeletal problem involving thorax

Design outcomes

Primary

MeasureTime frame
To determine changes in lung compliance during protamine administration to reverse heparin anticoagulation.Timepoint: â?¢Post intubation (baseline) â?¢Pre-protamine â?¢Every minute till 10 minutes after protamine test dose (PTD) has been administered—

Secondary

MeasureTime frame
To study the changes in Right ventricle (RV) function (FAC, TAPSE, Sâ?? & RVSP) during protamine administration, and its correlation with change in lung complianceTimepoint: â?¢ Post intubation (baseline) â?¢ Pre-protamine â?¢ 5 minutes and 10 minutes after protamine test dose (PTD) has been administered—

Countries

India

Contacts

Public ContactDr Prabhat Tewari

SGPGIMS, Lucknow

ptewari123@yahoo.co.in05224904483

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026