NCT04826848

Brief Summary

There is no clear consensus on the use of pneumonia severity index (PSI) developed for community-acquired pneumonia in hospital-acquired pneumonia cases. In another aspect, PSI is a relatively difficult scoring system that includes many parameters. This study evaluated whether lactate clearance could be used as a mortality marker instead of PSI in hospital-acquired pneumonia. As a result, lactate clearance was lower in the mortal group and when the diagnostic statistics were evaluated, it was seen that the sensitivity and specificity rates were significantly higher. In conclusion, lactate clearance has been evaluated as a strong predictor of mortality in hospital-acquired pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

May 26, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 30, 2021

Last Update Submit

May 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    28-day mortality

    28 day

Interventions

LactateDIAGNOSTIC_TEST

We will evauate the lactate clearance of the patients in 6 hours period. Lactate clearance = \[(Initial lactate - 6th hour lactate) / Initial lactate\] \* 100

Eligibility Criteria

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

Patients at the age of 18 and over with at least 48 hours of hospitalization within the specified study date range, who were discharged from the hospital within the last 14 days related to this hospitalization, who were re-admitted to the adult emergency department and were diagnosed with pneumonia were included in the study.

You may qualify if:

  • and over age, hospital-acquired pneumonia, emergency department admissions

You may not qualify if:

  • Patients who are pregnant or lactating, under 18 years of age, in the healthcare-associated pneumonia group, had mechanical ventilation at the last hospitalization, whose lactate level could not be studied for any reason at admission and 6th hour, had missing data used in pneumonia severity index calculation and/or who did not accept to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alp Şener, MD

    Ankara Yıldırım Beyazıt University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations