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]

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).

Study Overview

• Status: Unknown
• Conditions: ARDS, Human
• Intervention / Treatment: Diagnostic test: VWF measurement

• Study Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• (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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARDS group ,	Diagnostic test: VWF measurement; 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).; Other Names: IL6 measurement
non ARDS group	Diagnostic test: VWF measurement; 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).; Other Names: IL6 measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 21, 2020
• Primary Completion (Anticipated): March 20, 2021
• Study Completion (Anticipated): September 20, 2021

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: research ethical comittee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No