Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06197256
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Dysfunction in Critically Ill Covid-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements', 'timeFrame': 'Baseline and followup 3-5 days later', 'description': 'Regression analysis will be performed to check for association between these potential confounders and RV function, to be corrected for if applicable'}], 'primaryOutcomes': [{'measure': 'Delta MPAP', 'timeFrame': '3-5 days', 'description': 'Difference in MPAP, measured at baseline and at followup'}, {'measure': 'Delta RV GLS', 'timeFrame': '3-5 days', 'description': 'Difference in RV GLS, measured at baseline and at followup'}, {'measure': 'Delta TAPSE', 'timeFrame': '3-5 days', 'description': 'Difference in TAPSE, measured at baseline and at followup'}], 'secondaryOutcomes': [{'measure': 'Delta EF', 'timeFrame': '3-5 days', 'description': 'Difference in EF, measured at baseline and at followup'}, {'measure': 'Delta CI', 'timeFrame': '3-5 days', 'description': 'Difference in CI, measured at baseline and at followup'}, {'measure': 'Delta LV GLS', 'timeFrame': '3-5 days', 'description': 'Difference in LV GLS, measured at baseline and at followup'}, {'measure': 'Rates of LV failure detected by LV GLS compared to EF', 'timeFrame': 'Presented both at baseline and followup', 'description': 'Comparison of the amount of patients with LV failure for LV GLS and for EF, presented at both timepoints'}, {'measure': 'Rates of RV failure detected by RV GLS compared to TAPSE', 'timeFrame': 'Presented both at baseline and followup', 'description': 'Comparison of the amount of patients with RV failure for RV GLS and for TAPSE, presented at both timepoints'}, {'measure': 'Associations between levels of pulmonary hypertension, PEEP, peak pressures, central venous pressures and measurements', 'timeFrame': '3-5 days', 'description': 'Regression analysis will be performed to check for association between these potential confounders'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'ARDS, Human', 'Cardiac Failure', 'Right Ventricular Dysfunction', 'Left Ventricular Dysfunction', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", in which we analysed the echocardiographic data collected both at baseline when patients where included and 3-5 days later for followup.', 'detailedDescription': 'We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure" which was conducted in 2020/2021 during the COVID-19 pandemic on patients with ARDS due to COVID and requiring mechanical ventialtion. Patients underwent echocardiography at baseline, and were then randomized either to control, or treatment with inhaled nitric oxide, starting at 80ppm and then 40ppm. Followup echocardiography was performed 3-5 days later, and all echocardiographies were conducted by highly experienced sonographeres certified by the European Association of Cardiovascular Imaging. Analysis of these cardiac ultrasounds focused on the amount of patients showing signs of pulmonary hypertension, right ventricular failure and left ventricular failure. Several parameters were used to estimate these, and we also aimed to evalute the utility of more novel measures such as RV and LV GLS for this use in the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A population studied in the trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", consisting of 40 patients recruited in the ICU at Danderyds Hospital at the height of the COVID-19 pandemic. The study population consisted of critically ill patients requiring mechanical ventilation suffering from verified COVID-19 with ARDS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18.\n* Positive PCR for COVID-19.\n* Admission to the ICU.\n* Endotracheal intubation and mechanical ventilation.\n* Severe hypoxemia, defined by PaO2/FiO2 \\< 300 mmHg.\n* Inclusion in the trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure"\n\nExclusion Criteria:\n\n* Endotracheal intubation for \\>72h before inclusion.\n* Do not resuscitate order or other limitation of care.\n* Known pregnancy.\n* Cases where the treating physician opposes inclusion due to safety concerns or considerations that renders inclusion unfeasible.\n* Not having had echocardiography performed during the trial period (exclusion criteria for this sub-study).'}, 'identificationModule': {'nctId': 'NCT06197256', 'briefTitle': 'Cardiac Dysfunction in Critically Ill Covid-19 Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'Right and Left Ventricular Dysfunction in Critically Ill COVID-19 Patients and the Effects of Inhaled Nitric Oxide: A Sub-study of a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'iNO Cardiac'}}, 'contactsLocationsModule': {'locations': [{'zip': '182 57', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Daniel Törnberg, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KI DS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}