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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581316
• Other study ID #: MAC2022-N
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2022
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Infections
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of procalcitonin	blood test	Each participant will be evaluated for 4 weeks
Primary	Level of thrombocyte	blood test	Each participant will be evaluated for 4 weeks
Primary	Level of leukocyte	blood test	Each participant will be evaluated for 4 weeks