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The Role of Salivary Alpha Amylase in Sepsis

The Role of Salivary Alpha Amylase in Sepsis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04549740
Enrollment
60
Registered
2020-09-16
Start date
2020-09-15
Completion date
2024-03-01
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Detailed description

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. Although sepsis is one of the oldest syndromes in medicine, it is a challenging healthcare problem even nowadays. In spite of the era of modern an¬tibiotics and intensive therapy sepsis is still one of the leading causes of morbidity and mortality. Based on the novel results and advances of pathobiology, management and epidemiology of sepsis, the definitions of the syndrome have been changed recently. Sepsis-3 consensus de¬fines sepsis as a life-threatening organ dysfunc¬tion caused by a dysregulated host response to infection. The diagnosis of sepsis is most often not easy especially in newborns or in patients whose im¬mune response is not adequate. Therefore, it is of most importance to introduce diagnostic biomarkers which can predict or verify systemic inflammation as early as possible. These tests should also be applicable for monitoring of the disease progression and efficacy of therapy as well. 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. sAA is a digestive enzyme that breaks down starch into glucose and maltose, and enzymatic activity (in Units/ml) is used as a proxy for sAA concentration. The use of salivary alpha amylase as a marker of sympathetic activity seems justified. Salivary alpha amylase release from the salivary glands is under strong control of local sympathetic nerves. Its salivary concentration rapidly increases during acute stress, and its use as a marker of sympathetic activation is also validated by pharmacological studies.

Interventions

DIAGNOSTIC_TESTsalivary alpha amylase level measurement

Saliva samples will be obtained to estimate salivary alpha amylase

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
correlation of salivary amylase level and procalcitonin level in sepsis.Through study completion average of 6 monthscorrelation of salivary amylase level and procalcitonin level in the newly diagnosed patients with sepsis.

Secondary

MeasureTime frameDescription
correlation of salivary amylase level with mortalityduring 28 follow up days of the patientscorrelation of salivary amylase level with mortality with follow up of the patients

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026