NCT04105400

Brief Summary

correlation between procalcitonin levels and the severity of sepsis and it's possibility to be used as a prognostic marker in patients with sepsis and severe sepsis

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

September 25, 2019

Last Update Submit

September 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • role of procalcitonin in early diagnosis of sepsis

    Descriptive cross sectional study would be conducted on adult patients \>18 years who were admitted to intensive care unit of Assiut University Hospital with symptoms of systemic infection and with a clinical suspicion of sepsis as guided by the ICU physician

    Baseline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients will be subjected to: * Full history \& clinical examination. * Routine laboratory investigations including: * Complete blood count (CBC), with special attention to white blood cells (number \& diff.) * Serum C-reactive protein (CRP) level * Erythrocyte sedimentation rate (ESR) Special investigations: ● Blood culture : Blood culture will be processed using the Bact/Alert continuous blood culture monitoring system. Bacteria from positive blood cultures will further identified using standard laboratory methods. Cultures that did not indicate growth within 5 days of incubation will be considered negative. ● Serum procalcitonin will be estimated by ELISA kit.

You may qualify if:

  • adult patients \>18 years who were admitted to intensive care unit of Assiut University Hospital with symptoms of systemic infection and with a clinical suspicion of sepsis as guided by the ICU physician

You may not qualify if:

  • Patients above 70 years of age
  • Patients who received antibiotic therapy within three days prior to sample collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Granic M, Zdravkovic D, Krstajic S, Kostic S, Simic A, Sarac M, Ivanovic N, Radovanovic D, Dikic S, Kovcin V. Totally implantable central venous catheters of the port-a-cath type: complications due to its use in the treatment of cancer patients. J BUON. 2014 Jul-Sep;19(3):842-6.

    PMID: 25261677BACKGROUND
  • Vincent JL, Marshall JC, Namendys-Silva SA, Francois B, Martin-Loeches I, Lipman J, Reinhart K, Antonelli M, Pickkers P, Njimi H, Jimenez E, Sakr Y; ICON investigators. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med. 2014 May;2(5):380-6. doi: 10.1016/S2213-2600(14)70061-X. Epub 2014 Apr 14.

    PMID: 24740011BACKGROUND
  • Karlsson S, Heikkinen M, Pettila V, Alila S, Vaisanen S, Pulkki K, Kolho E, Ruokonen E; Finnsepsis Study Group. Predictive value of procalcitonin decrease in patients with severe sepsis: a prospective observational study. Crit Care. 2010;14(6):R205. doi: 10.1186/cc9327. Epub 2010 Nov 15.

    PMID: 21078153BACKGROUND
  • Ruiz-Alvarez MJ, Garcia-Valdecasas S, De Pablo R, Sanchez Garcia M, Coca C, Groeneveld TW, Roos A, Daha MR, Arribas I. Diagnostic efficacy and prognostic value of serum procalcitonin concentration in patients with suspected sepsis. J Intensive Care Med. 2009 Jan-Feb;24(1):63-71. doi: 10.1177/0885066608327095. Epub 2008 Dec 2.

    PMID: 19054806BACKGROUND
  • Kim JH, Seo JW, Mok JH, Kim MH, Cho WH, Lee K, Kim KU, Jeon D, Park HK, Kim YS, Kim HH, Lee MK. Usefulness of plasma procalcitonin to predict severity in elderly patients with community-acquired pneumonia. Tuberc Respir Dis (Seoul). 2013 May;74(5):207-14. doi: 10.4046/trd.2013.74.5.207. Epub 2013 May 31.

    PMID: 23750168BACKGROUND
  • Novotny A, Emmanuel K, Matevossian E, Kriner M, Ulm K, Bartels H, Holzmann B, Weighardt H, Siewert JR. Use of procalcitonin for early prediction of lethal outcome of postoperative sepsis. Am J Surg. 2007 Jul;194(1):35-9. doi: 10.1016/j.amjsurg.2006.10.026.

    PMID: 17560906BACKGROUND
  • Lee CC, Chen SY, Tsai CL, Wu SC, Chiang WC, Wang JL, Sun HY, Chen SC, Chen WJ, Hsueh PR. Prognostic value of mortality in emergency department sepsis score, procalcitonin, and C-reactive protein in patients with sepsis at the emergency department. Shock. 2008 Mar;29(3):322-7. doi: 10.1097/shk.0b013e31815077ca.

    PMID: 17724429BACKGROUND
  • Peters RP, Twisk JW, van Agtmael MA, Groeneveld AB. The role of procalcitonin in a decision tree for prediction of bloodstream infection in febrile patients. Clin Microbiol Infect. 2006 Dec;12(12):1207-13. doi: 10.1111/j.1469-0691.2006.01556.x.

    PMID: 17121627BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

mohamed abdelnaser mahmoud Ali, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

September 30, 2019

Record last verified: 2019-09