The Role of Salivary Alpha Amylase in Sepsis

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04549740
Collaborator
(none)
60
1
5.5
10.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: salivary alpha amylase level measurement

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Role of Salivary Alpha Amylase in Sepsis
Actual Study Start Date :
Sep 15, 2020
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Mar 1, 2021

Outcome Measures

Primary Outcome Measures

  1. correlation of salivary amylase level and procalcitonin level in sepsis. [Through study completion average of 6 months]

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

Secondary Outcome Measures

  1. correlation of salivary amylase level with mortality [during 28 follow up days of the patients]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tarek Abdel Hay Tanta El Gharbyia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
tarek abdel hay mostafa, principle investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT04549740
Other Study ID Numbers:
  • salivary amylase in sepsis
First Posted:
Sep 16, 2020
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2020