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Completed

NCT Number: NCT04549740

The Role of Salivary Alpha Amylase in Sepsis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

salivary alpha amylase level measurement

Diagnostic Test

Saliva samples will be obtained to estimate salivary alpha amylase

Primary outcomes

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

    Time frame: Through study completion average of 6 months

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

Secondary outcomes

  1. correlation of salivary amylase level with mortality

    Time frame: during 28 follow up days of the patients

    correlation of salivary amylase level with mortality with follow up of the patients

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2020
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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