MedTrace Logo

Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2

NCT04998253 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-08-13

No results posted yet for this study

Summary

Summary Currently, the COVID-19 pandemic has overtaken health systems worldwide, exceeding the capacity of intensive care units. In addition to this, countries such as the United States have reported a decrease in the supplies of drugs such as Propofol and Midazolam (traditionally used as sedatives in patients with invasive mechanical ventilation), so in the absence until now of a specific treatment against SARS-COV-2 virus, improving the support strategies in patients in the severe spectrum of the disease Acute Respiratory Distress Syndrome (ARDS) is a priority.

Given the global state of emergency due to COVID-19, the use of sevoflurane has the potential to mitigate the shortages of sedative drugs, promote the recovery of patients with ARDS, and potentially reduce mortality.

A study will be conducted to evaluate the effect of sevoflurane as inhalation sedation in patients with ARDS secondary to SARS-COV2 compared to the standard. The primary objective of the study is to assess the difference in oxygenation, for which the calculation of the partial pressure of arterial oxygen to fractional inspired oxygen concentration ratio (PaO2 / FiO2) will be used at 24 and 48 hours. Also, the effect of the possible attenuation or inhibition of hypoxic pulmonary vasoconstriction will be evaluated by hemodynamic monitoring with a pulmonary artery catheter and transthoracic echocardiography and its possible effect on the right ventricle.

Outcome: we expect an improvement in oxygenation and consequently a reduction in the days of invasive mechanical ventilation, stay in the intensive care unit (ICU) and hospital. In addition to evaluating its possible anti-inflammatory effect and probably establishing a safe and effective alternative and possibly with greater benefits compared to standard intravenous sedation.

Conditions

  • Hypoxic Pulmonary Vasoconstriction
  • Hypoxemia
  • Acute Respiratory Distress Syndrome
  • SARS-CoV-2 Acute Respiratory Disease

Interventions

DRUG

Effects in oxygenation and hypoxic pulmonary vasoconstriction

Determination of the anti-inflammatory effect. The anti-inflammatory effect is assessed with serum measurement of interleukin 6 (IL-6), C-reactive protein (CRP), ferritin, DHL (lactic dehydrogenase), taken by venipuncture on admission, at 24 and 48 hours. The following measurements will be performed: pulmonary artery systolic and diastolic pressure (PASP, PADP respectively), central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), pulmonary vascular resistance (PVR), systemic vascular resistance (SVR), right ventricular stroke work (RVSW) and left ventricular work (LVSW). Stroke volume (and cardiac output) will be computed using the thermodilution technique averaging three consecutive injections with 10 ml of 0.9% saline solution.

Sponsors & Collaborators

  • Unidad Temporal COVID-19 en Centro Citibanamex

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2020-11-30
Completion
2021-05-15

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998253 on ClinicalTrials.gov