Endothelial Function, Inflammation and Organ Dysfunction in COVID-19

NCT04408365 | Unknown

• 1 other identifier: 282930
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients which require intensive care unit admission. In critically ill patients infected with COVID-19, approximately 15% had severe shock requiring medications to increase blood pressure. It appears that blood vessel tone is altered and microcirculation is not well regulated in patients with COVID-19. The underlying pathophysiology and contributing factors are unknown. The association with subsequent organ dysfunction and outcome is also unclear. Therefore, the investigators aim to investigate serial changes of relevant biomarkers in this population to improve the understanding of this disease, to investigate the association with clinically important outcomes and to find out how best to treat patients. The data will serve to develop strategies for individualised management of this high-risk group.

Conditions

COVID; Shock

Outcome Measures

Primary Outcomes (5)

• Change of plasma bio-adrenomedullin

  Change of plasma bio-adrenomedullin

  Day 1-7 after intensive care unit admission

• Change of plasma proenkephalin

  Change of plasma proenkephalin

  Day 1-7 after intensive care unit admission

• Change of plasma dipeptidyl peptidase-3

  Change of plasma dipeptidyl peptidase-3

  Day 1-7 after intensive care unit admission

• Change of plasma renin

  Change of plasma renin

  Day 1-7 after intensive care unit admission

• Change of plasma angiotensin II

  Change of plasma angiotensin II

  Day 1-7 after intensive care unit admission

Secondary Outcomes (6)

• Duration of vasodilatory shock

  7 and 28 days

• Acute kidney injury

  7 and 28 days

• Need for renal replacement therapy

  7 and 28 days

• Duration of ventilation

  7 and 28 days

• Duration of extracorporeal membrane oxygenation

  7 and 28 days

Study Arms (1)

COVID-19 patients

Adult COVID-19 patients admitted to intensive care units

Eligibility Criteria

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

Study Population

Adult COVID-19 patients who are admitted in intensive care units

You may qualify if:

• Adult patients (≥ 18 years old) admitted to intensive care units
• Confirmed or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection resulting in coronavirus disease 2019 (COVID-19)

You may not qualify if:

• None

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

Guy's & St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Daily blood samples from ICU admission until day 7 and around the onset of vasodilatory shock Daily urine and RRT effluent fluid samples (if available) from ICU admission until day 7

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nuttha Lumlertgul, MD, PhD

  Guy's & St Thomas' Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlies Ostermann, MD, PhD

CONTACT

0044 207 188 3038; Marlies.Ostermann@gstt.nhs.uk

Nuttha Lumlertgul, MD, PhD

CONTACT

0044 207 188 3038; Nuttha.Lumlertgul@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: August 5, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

GB (1)