BurnsNCT05581316
An Investigation of the Effect of Types of Catheters on Bloodstream Infection in Patients With Major Burns: Prediction With Procalcitonin and Prognosis
A study testing 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 people with Burns, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Burns
- What is being tested?
- 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Organ dysfunctions or multiple organ failures • Antibiotics treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
.
- Conditions
- Burns
- Being tested
- 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.
- Keywords
- burns, Blood stream infections, procalcitonin
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| patients who use peripheral venous catheters | Experimental | 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 Receives: 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. |
| patients who use venous catheters | Experimental | 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of procalcitonin
blood test
Measured: Each participant will be evaluated for 4 weeks
Level of thrombocyte
blood test
Measured: Each participant will be evaluated for 4 weeks
Level of leukocyte
blood test
Measured: Each participant will be evaluated for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jan 2019
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ali ÇINAR, Hasan Kalyoncu University
- Investigators
- MURAT A ÇINAR, DR, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581316
- Sponsor's protocol ID
- MAC2022-N
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effect of Types of Catheters on Bloodstream Infection in Patients With Major Burns: Prediction With Procalcitonin and Prognosis
- ClinicalTrials.gov ID
- NCT05581316
- Acronym / sponsor ID
- MAC2022-N
- Conditions
- Burns
- Keywords
- burns, Blood stream infections, procalcitonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who use peripheral venous catheters | Experimental | 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.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 who use venous catheters | Experimental | 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.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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Organ dysfunctions or multiple organ failures • Antibiotics treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | patients who use peripheral venous catheters, patients who use venous catheters |
Primary outcome
Level of procalcitonin
Time frame: Each participant will be evaluated for 4 weeks
blood test
Level of thrombocyte
Time frame: Each participant will be evaluated for 4 weeks
blood test
Level of leukocyte
Time frame: Each participant will be evaluated for 4 weeks
blood test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Results publication: PubMed 3390820Manda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MURAT A ÇINAR, DR principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Burns, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of procalcitonin (time frame: Each participant will be evaluated for 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05581316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.