Pulmonary Artery Pressure in COVID-19 Survivors

NCT05993338 | Completed

• 1 other identifier: MD.22.04.638
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Post COVID-19 pulmonary hypertension can develop as a result of lung parenchymal damage and altered pulmonary circulation induced by COVID-19 infection. It has been proposed that this type of PH should be considered a combination between PH of group 3 (due to interstitial fibrosis and alveolar inflammation) and 4 (induced by thrombotic/thromboembolic processes, endothelial injury, or, at least, hypoxic vasoconstriction). Right heart catheterization (RHC) is the gold standard for assessing pulmonary hemodynamics and is mandatory for confirming the diagnosis of pulmonary hypertension (PH), assessing the severity of hemodynamic impairment, and performing vasoreactivity testing in selected patients

Conditions

Pulmonary Hypertension Secondary

Keywords

pulmonary artery pressure; COVID-19 survivors; right heart catheterization

Outcome Measures

Primary Outcomes (1)

• Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC)

  The pulmonary artery blood sample is withdrawn using the distal yellow port, and mixed venous oxygen saturation (SvO2) is obtained. Arterial saturation (SaO2) has to be obtained separately so as to determine the cardiac output (CO), using the Fick's method; CO, L/min = VO2/ \[(SaO2 - SvO2) x Hb x 13.4)\], where VO2 = 125 mL O2/min x BSA, In elderly patients (age ≥70 years), use 110 mL O2 x BSA for VO2, BSA = \[(Height, cm x Weight, kg)/ 3,600\]

  1.5 year

Study Arms (1)

assess pulmonary hemodynamics in COVID-19 survivors

EXPERIMENTAL

COVID-19 survivors from a moderate/severe COVID-19 pulmonary infection according to WHO COVID-19 clinical severity classification, ≥ 18 years, with residual symptoms and signs suggestive of pulmonary hypertension and not explained by other condition

Diagnostic Test: right heart catheterization (RHC).

Interventions

right heart catheterization (RHC). DIAGNOSTIC_TEST

Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC).

assess pulmonary hemodynamics in COVID-19 survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 survivors from a moderate/severe COVID-19 pulmonary infection according to WHO COVID-19 clinical severity classification , ≥ 18 years, with residual symptoms and signs suggestive of pulmonary hypertension and not explained by other condition.

You may not qualify if:

• Previous diseases that could explain the existence of PH e.g. cardiovascular, pulmonary diseases or history of pulmonary thromboembolism.
• Hemodynamic instability.
• Absolute contraindications to RHC placement include:
• Infection at the insertion site.
• The presence of a right ventricular assist device.
• Insertion during cardiopulmonary bypass.
• Lack of consent.
• Relative contraindications to RHC placement include:
• Coagulopathy (INR \>1.5), thrombocytopenia (platelet count \<50,000/microL).
• Electrolyte disturbances.
• Severe acid-base disturbances.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

faculty of medicine Mansoura university

Al Mansurah, Egypt

Location

Study Officials

• Mohamed Abd Elmoniem

  assistant lecturer chest medicine Mansoura university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer chest medicine-Mansoura univerisity-Mansoura-Egypt

Model Details: assess pulmonary hemodynamics in COVID-19 survivors

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 15, 2023
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)