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]

ARDS, Human Clinical Trial

Official title:

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]

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04317469
• Other study ID #: research ethical comittee
• Status: Not yet recruiting
• Start date: March 21, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: March 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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