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CompletedNCT05581316Updated Oct 14, 2022

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

An interventional study of 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. in Burns, sponsored by Hasan Kalyoncu University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-10-14.

Sponsored by Hasan Kalyoncu University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Jan 2019, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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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02

Conditions studied

  • Burns

Keywords

  • burns
  • Blood stream infections
  • procalcitonin
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 34 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hasan Kalyoncu University is the lead sponsor of 161 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

Exclusion Criteria:

  • Organ dysfunctions or multiple organ failures • Antibiotics treatment
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • 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.

  • 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.

Interventions

  • Diagnostic testPatients' 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.

06

What researchers measure

Primary outcomes

  1. Level of procalcitonin

    blood test

    Time frame: Each participant will be evaluated for 4 weeks

  2. Level of thrombocyte

    blood test

    Time frame: Each participant will be evaluated for 4 weeks

  3. Level of leukocyte

    blood test

    Time frame: Each participant will be evaluated for 4 weeks

07

Study locations

1 site
  • Hasan Kalyoncu University
    Gaziantep, 27000, Turkey
08

References and documents

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. PubMed 3390820 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05581316
Lead sponsor
Hasan Kalyoncu University
Responsible party
Murat Ali ÇINAR (assistive professor, Hasan Kalyoncu University) — Principal investigator
First posted
Oct 14, 2022
Start date
Jan 1, 2019
Primary completion
Mar 1, 2022
Completion
Apr 1, 2022
Last update
Oct 14, 2022

Study contacts

MURAT A ÇINAR, DR
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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