The Role of Salivary Alpha Amylase in Sepsis

NCT04549740 | Completed DMC

• 1 other identifier: salivary amylase in sepsis
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Critical illness may be induced by different underlying life-threatening diseases, such as infection, sepsis, trauma, respiratory insufficiency or hypoxia and severe neurological status. The associated endocrine, nervous, metabolic and immunological changes are defined as acute stress syndrome. Salivary alpha-amylase is secreted from the salivary glands mainly in response to beta-adrenergic stimuli. Salivary alpha-amylase (sAA) has gained rapid popularity as a non-invasive marker of sympathetic nervous system (SNS) activity.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• correlation of salivary amylase level and procalcitonin level in sepsis.

  correlation of salivary amylase level and procalcitonin level in the newly diagnosed patients with sepsis.

  Through study completion average of 6 months

Secondary Outcomes (1)

• correlation of salivary amylase level with mortality

  during 28 follow up days of the patients

Interventions

salivary alpha amylase level measurement DIAGNOSTIC_TEST

Saliva samples will be obtained to estimate salivary alpha amylase

Eligibility Criteria

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

Study Population

The newly diagnosed patients with sepsis or septic shock according to Sepsis-3 consensus definition using SOFA score aged more than 18 years old.

You may qualify if:

• The newly diagnosed patients with sepsis according to Sepsis-3 consensus definition using SOFA score
• The newly diagnosed patients with septic shock according to Sepsis-3 consensus definition using SOFA score
• aged more than 18 years old.

You may not qualify if:

• Evidence of an immunocompromised as malignancy,
• received corticosteroids,
• recieved chemotherapy,
• recieved radiotherapy
• recieved cytotoxic drugs
• advanced hepatic disease
• renal disease
• pregnancy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

venous sample will be withdrawn to estimate serum procalcitonin level. Saliva samples will be obtained to estimate salivary alpha amylase.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 16, 2020
• Study Start: September 15, 2020
• Primary Completion: February 20, 2024
• Study Completion: March 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

EG (1)