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Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19

Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to SARS-CoV-2 Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04556864
Enrollment
67
Registered
2020-09-21
Start date
2020-10-01
Completion date
2021-04-01
Last updated
2020-09-21

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

Conditions

ARDS, Human, Covid19, Hemodynamic Instability

Keywords

COVID, hemodynamic monitoring, ARDS

Brief summary

The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection

Interventions

None listed

Sponsors

Edwards Lifesciences
CollaboratorINDUSTRY
Juan Victor Lorente
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 18 years old. * Patients that are classified as a confirmed case according to criteria established by the Spanish Ministry of Health in its Technical Document updated on March 31, 2020. This defines a confirmed case as a case that meets laboratory criteria (Positive PCR test for any of the SARS-CoV-2 genes). * Patients admitted to ICU. * Presence of Kirby index (PaFi) less than or equal to 300 mm Hg, with PEEP or CPAP greater than or equal to 5 cmH2O. * Need for radial artery cannulation for hemodynamic monitoring and/or repeated monitoring of blood gases at the discretion of the responsible physician. * Patients who agree (or a representative of the patient if sedated) to participate in study and who provide written informed consent.

Exclusion criteria

* Patients being treated with veno-venous or veno-arterial ECMO * Patient with therapeutic restrictions due to life support * Patient who presents a complication that requires surgical intervention.

Design outcomes

Primary

MeasureTime frameDescription
Total amount of hypotension5 daysHypotension will be defined as a hemodynamic event that occurs when the MAP falls below 65 mmHg for a minimum duration of 1 minute (3 consecutive recordings of 1 minute or more between two consecutive falls of the MAP).

Secondary

MeasureTime frameDescription
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume variation)5 daysWe will obtain hemodynamic data for the first 5 days after the patient enters the study
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Cardiac index)5 daysWe will obtain hemodynamic data for the first 5 days after the patient enters the study
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor ( HPI)5 daysWe will obtain hemodynamic data for the first 5 days after the patient enters the study
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Eadyn)5 daysWe will obtain hemodynamic data for the first 5 days after the patient enters the study
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (dp/dt max,)5 daysWe will obtain hemodynamic data for the first 5 days after the patient enters the study
Presence of treatment with noradrenaline; presence of treatment with dobutamine, presence of treatment with other vasoactive/ionotropic/hypotensive drugs5 daysstart time, time of dose change, current dose
Furosemide treatmentDaily during 5 daysdose/24 hours
Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume)5 daysWe will obtain hemodynamic data for the first 5 days after the patient enters the study
Atrial fibrillation5 daysPresence, start time and end time
Acute kidney injuryDaily during 5 daysPresence and degree with KDIGO definition
Continuous renal replacement therapies5 daysStart and end date/time, dialyzing flow, replacement flow, daily balance.
Need for Hemadsorption5 daysStart and end date/time, blood flow.
Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)5 daysStart and end date/time
Corticoid treatment.5 daysStart and end date/time
Daily diuresis, daily water balance, accumulated water balance since ICU admission, daily parenteral nutrition volume, and daily enteral nutrition volume.Daily during 5 daysml/24 h

Countries

Spain

Contacts

Primary ContactJuan Victor Lorente, MD
juanvictor.lorente@gmail.com695881448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026