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

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
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.
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Burns focused on measuring burns, Blood stream infections, procalcitonin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients who use peripheral venous catheters

patients who use venous catheters

Arm Description

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

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

Outcomes

Primary Outcome Measures

Level of procalcitonin
blood test
Level of thrombocyte
blood test
Level of leukocyte
blood test

Secondary Outcome Measures

Full Information

First Posted
October 11, 2022
Last Updated
October 12, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05581316
Brief Title
An Investigation of the Effect of Types of Catheters on Bloodstream Infection in Patients With Major Burns: Prediction With Procalcitonin and Prognosis
Official Title
An Investigation of the Effect of Types of Catheters on Bloodstream Infection in Patients With Major Burns: Prediction With Procalcitonin and Prognosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
burns, Blood stream infections, procalcitonin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients who use peripheral venous catheters
Arm Type
Experimental
Arm Description
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
Arm Title
patients who use venous catheters
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of procalcitonin
Description
blood test
Time Frame
Each participant will be evaluated for 4 weeks
Title
Level of thrombocyte
Description
blood test
Time Frame
Each participant will be evaluated for 4 weeks
Title
Level of leukocyte
Description
blood test
Time Frame
Each participant will be evaluated for 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MURAT A ÇINAR, DR
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3390820
Citation
Manda T, Nishigaki F, Mori J, Shimomura K. Important role of serotonin in the antitumor effects of recombinant human tumor necrosis factor-alpha in mice. Cancer Res. 1988 Aug 1;48(15):4250-5.
Results Reference
result

Learn more about this trial

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

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