An Investigation of the Effect of Types of Catheters on Bloodstream Infection in Patients With Major Burns: Prediction With Procalcitonin and Prognosis

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Completed
CT.gov ID
NCT05581316
Collaborator
(none)
34
1
2
39
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Study Details

Study Description

Brief Summary

Bloodstream infections and catheter-related infections frequently occur in burn patients. It is important to correctly assess and manage these infections. The present study aimed to investigate the effects of catheter types used in major burn patients on bloodstream infections as well as to predict sepsis status and manage its prognosis using a procalcitonin biomarker.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Patients' procalcitonin, thrombocyte, and leukocyte levels were assessed every other day for 4 weeks, beginning on the first day they were admitted to the burn center.
N/A

Detailed Description

Aim:

Bloodstream infections and catheter-related infections frequently occur in burn patients. It is important to correctly assess and manage these infections. The present study aimed to investigate the effects of catheter types used in major burn patients on bloodstream infections as well as to predict sepsis status and manage its prognosis using a procalcitonin biomarker.

Materials and Methods:

A total of 34 patients admitted to the intensive care unit of the Burn Center, December 25th State Hospital, Ministry of Health, between 2019 and 2022, were included in the study conducted at the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hasan Kalyoncu University.

Study inclusion criteria

  • Conscious and cooperative (based on the Glasgow coma score; eyes open spontaneously (E): 4, obeys commands (M): 6, oriented verbal (V) response: 5; and E4M6V5);

  • Enterally fed, aged over 18 years;

  • No antibiotic treatment from hospitalization to discharge;

  • Meets the major burn class standards defined by the American Burn Association; and

  • Stable hemodynamic values and vital signs with no need for inotropic medication.

Study exclusion criteria

  • Organ dysfunctions or multiple organ failures

  • Antibiotics treatment Nutrient types and diets were the same in all groups. All patients received similar standard medical care and treatment from the time of emergency admission and acute care of the burn injury until the time of discharge. In addition, types and numbers of clinical interventions, such as surgical debridement and grafting, were similar in all groups. All patients who were included in this study were assessed for four weeks from the first day of hospitalization and taken to the treatment program.

Patients included in the study were divided into two groups based on whether they used PVCs or CVCs. Patients' procalcitonin, thrombocyte, and leukocyte levels were assessed every other day for 4 weeks, beginning on the first day they were admitted to the burn center. The above examinations at the Laboratories of the December 25th State Hospital, Ministry of Health of the Republic of Turkey, were retrieved retrospectively from the hospital database.

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Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
An Investigation of the Effect of Types of Catheters on Bloodstream Infection in Patients With Major Burns: Prediction With Procalcitonin and Prognosis
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients who use peripheral venous catheters

Patients' procalcitonin, thrombocyte, and leukocyte levels were assessed every other day for 4 weeks, beginning on the first day they were admitted to the burn center. The above examinations at the Laboratories of the December 25th State Hospital, Ministry of Health of the Republic of Turkey, were retrieved retrospectively from the hospital database

Diagnostic Test: Patients' procalcitonin, thrombocyte, and leukocyte levels were assessed every other day for 4 weeks, beginning on the first day they were admitted to the burn center.
This patients who were included in this study were assessed for four weeks from the first day of hospitalization and taken to the treatment program. All patients who use peripheral venous catheters in this group.

Experimental: patients who use venous catheters

Patients' procalcitonin, thrombocyte, and leukocyte levels were assessed every other day for 4 weeks, beginning on the first day they were admitted to the burn center. The above examinations at the Laboratories of the December 25th State Hospital, Ministry of Health of the Republic of Turkey, were retrieved retrospectively from the hospital database

Diagnostic Test: Patients' procalcitonin, thrombocyte, and leukocyte levels were assessed every other day for 4 weeks, beginning on the first day they were admitted to the burn center.
This patients who were included in this study were assessed for four weeks from the first day of hospitalization and taken to the treatment program. All patients who use peripheral venous catheters in this group.

Outcome Measures

Primary Outcome Measures

  1. Level of procalcitonin [Each participant will be evaluated for 4 weeks]

    blood test

  2. Level of thrombocyte [Each participant will be evaluated for 4 weeks]

    blood test

  3. Level of leukocyte [Each participant will be evaluated for 4 weeks]

    blood test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Conscious and cooperative (based on the Glasgow coma score; eyes open spontaneously (E): 4, obeys commands (M): 6, oriented verbal (V) response: 5; and E4M6V5);

  • Enterally fed, aged over 18 years;

  • No antibiotic treatment from hospitalization to discharge;

  • Meets the major burn class standards defined by the American Burn Association; and

  • Stable hemodynamic values and vital signs with no need for inotropic medication.

Exclusion Criteria:
  • Organ dysfunctions or multiple organ failures • Antibiotics treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hasan Kalyoncu University Gaziantep Turkey 27000

Sponsors and Collaborators

  • Hasan Kalyoncu University

Investigators

  • Principal Investigator: MURAT A ÇINAR, DR, Study Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murat Ali ÇINAR, assistive professor, Hasan Kalyoncu University
ClinicalTrials.gov Identifier:
NCT05581316
Other Study ID Numbers:
  • MAC2022-N
First Posted:
Oct 14, 2022
Last Update Posted:
Oct 14, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Murat Ali ÇINAR, assistive professor, Hasan Kalyoncu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2022