Evaluation of Von Willebrand Factor as a Marker For Early Diagnosis of Acute Respiratory Distress Syndrome (A.R.D.S) in Comparison to Interleukin 6 [IL-6]

NCT04317469 | Unknown

• 1 other identifier: research ethical comittee
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this prospective study of 60patients, we tested the hypothesis That markedly elevated levels of plasma von Willebrand factor (VWF) a marker of endothelial cell injury might predict the development of acute respiratory distress syndrome (A.R.D.S) in risky patients. We compared our result to IL.6 as control biomarker for A.R.D.S development. Acute lung injury was quantified on two -point scoring system (Berlin definition of ARDS and Murray score of acute lung injury). Plasma levels of both vWF and IL.6 were be measured on T=0 i.e. (at start of the study once the patient considered to be risky for A.R.D.S development to obtain their baseline levels), T=48 (after 48 hours), and T=72 (after 72 hours).

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

• level of vwf at 72 hours

  Plasma levels of both vWF and IL.6 were be measured on T=0 i.e. (at start of the study once the patient considered to be risky for A.R.D.S development to obtain their baseline levels), T=48 (after 48 hours), and T=72 (after 72 hours).

  72 hours

Study Arms (2)

ARDS group ,

Diagnostic Test: VWF measurement

non ARDS group

Diagnostic Test: VWF measurement

Interventions

VWF measurement DIAGNOSTIC_TEST

Plasma levels of both vWF and IL.6 were be measured on T=0 i.e. (at start of the study once the patient considered to be risky for A.R.D.S development to obtain their baseline levels), T=48 (after 48 hours), and T=72 (after 72 hours).

Also known as: IL6 measurement

ARDS group ,; non ARDS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 patients, admitted to the ICUs, staying \>24 hrs will be randomly assigned to enter this study.

You may qualify if:

• Patients between 18 and 80 years old of both sexes.
• risk factor for development of acute respiratory distress syndrome or acute lung injury either by:
• Direct lung injury includes: Severe pneumonia (infection), Breathing a vomited stomach contents (aspiration), Breathing harmful fumes or smoke, severe trauma to the chest or other accident that bruises the lungs.
• Indirect lung injury includes: sepsis, Severe injury or trauma with shock, blood transfusions , drug overdose acute pancreatitis, fracture of the long bones, near drowning ,anaphylaxis, uremia, fat embolus , and intracranial insult.

You may not qualify if:

• (1) pregnancy;
• (2) a preexisting medical condition with a life expectancy less than 3 months
• (3) evidence of cardiogenic pulmonary edema
• (4) age under 18 years old or above 80 years old
• (5) late stages of liver cell failure, renal failure
• (6) severe myocardial infarction
• (7) deep coma.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthiology and ICU , faculty of medicine , Ain Shams univeristy

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 23, 2020
• Study Start: March 21, 2020
• Primary Completion: March 20, 2021
• Study Completion: September 20, 2021
• Last Updated: March 23, 2020

Record last verified: 2020-03