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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: 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.

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.

.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey, 27000
    • Hasan Kalyoncu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of procalcitonin	blood test	Each participant will be evaluated for 4 weeks
Level of thrombocyte	blood test	Each participant will be evaluated for 4 weeks
Level of leukocyte	blood test	Each participant will be evaluated for 4 weeks

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University
• Investigators: Principal Investigator: MURAT A ÇINAR, DR, Study Principal Investigator

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: burns; procalcitonin; Blood stream infections
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Wounds and Injuries; Sepsis; Burns; Infections
• Other Study ID Numbers: MAC2022-N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No