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Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients

Primary Purpose

Sepsis, Acetaminophen, Fever

Status
Not yet recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Acetaminophen
Ibuprofen
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older Under 80 years of age Willing to participate in the study Diagnosed with sepsis according to the latest current guidelines Having a fever >38°C With no known history of adverse reactions to the active ingredient of the medication to be used" Exclusion Criteria: Under 18 years of age or over 80 years of age Not willing to participate in the study With a known history of adverse reactions to study medications Having a fever <38°C Pregnant individuals Individuals with advanced systemic illness Those with malignancies Patients with chronic liver and kidney disease Using sedative and analgesic neuro-psychiatric drugs With a history of psychological and neurological diseases"

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Acetaminophen

Ibuprofen

Arm Description

Adult patients diagnosed with sepsis according to the latest current guidelines, who have agreed to participate in the study or have provided consent by their relatives, and received 1g of acetaminophen for fever management.

Adult patients diagnosed with sepsis according to the latest current guidelines, who have agreed to participate in the study or have provided consent by their relatives, and received 400 mg of ıbuprofen for fever management.

Outcomes

Primary Outcome Measures

Fever
Body temperature, celcius

Secondary Outcome Measures

Heart Rate
Heart rate per minute
Blood Pressure
Systolic and diastolic blood pressure in mmHg
Oxygen saturation
Measured as a percentage through capillary measurement

Full Information

First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT06061575
Brief Title
Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients
Official Title
Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients: A Randomized Double-Blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

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

5. Study Description

Brief Summary
This is a randomized double-blind controlled study with the primary aim of scientifically evaluating the potential effects of paracetamol and ibuprofen in the management of sepsis by comparing their fever-reducing efficacy in septic patients. Sepsis is recognized as a severe form of systemic inflammatory response syndrome (SIRS) characterized by organ dysfunction resulting from severe infections. This study aims to address a significant aspect of fever management in septic patients by objectively assessing the fever-reducing potential of paracetamol and ibuprofen.
Detailed Description
This is a randomized double-blind controlled study with the primary aim of scientifically evaluating the potential effects of paracetamol and ibuprofen in the management of sepsis by comparing their fever-reducing efficacy in septic patients. Sepsis is recognized as a severe form of systemic inflammatory response syndrome (SIRS) characterized by organ dysfunction resulting from severe infections. This study aims to address a significant aspect of fever management in septic patients by objectively assessing the fever-reducing potential of paracetamol and ibuprofen. In addition to assessing the fever-reducing efficacy of paracetamol and ibuprofen, this study will also evaluate their ability to provide symptomatic relief. The effects of paracetamol and ibuprofen on vital signs in septic patients will be examined to understand the overall course of the clinical condition. The analysis of the side effect profile aims to provide a comprehensive view of the safety and tolerability of both drugs. The significance of this study can be explained by the critical role of fever regulation in sepsis management. Commonly used drugs like paracetamol and ibuprofen are widely employed to reduce fever and alleviate symptoms. However, there is limited data regarding the efficacy and safety of these drugs in septic patients. This research will help us better understand the role of these drugs in fever management in septic patients and contribute to optimizing treatment strategies. The findings of this study may guide clinical practice and establish a stronger scientific foundation for the management of septic patients. This research may bring a new perspective to clinical practices regarding fever management in septic patients. By providing scientific data on whether commonly used drugs like paracetamol and ibuprofen can contribute to sepsis treatment, it may enhance the more effective management of patients. If it is demonstrated that paracetamol and ibuprofen can be used effectively and safely in septic patients, treatment optimization can be achieved with appropriate dosages and under suitable conditions. This may enable patients to achieve more effective fever control. The results of the research may offer a better scientific basis for the use of drugs like paracetamol and ibuprofen in septic patients in clinical settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Acetaminophen, Fever, Ibuprofen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen
Arm Type
Other
Arm Description
Adult patients diagnosed with sepsis according to the latest current guidelines, who have agreed to participate in the study or have provided consent by their relatives, and received 1g of acetaminophen for fever management.
Arm Title
Ibuprofen
Arm Type
Other
Arm Description
Adult patients diagnosed with sepsis according to the latest current guidelines, who have agreed to participate in the study or have provided consent by their relatives, and received 400 mg of ıbuprofen for fever management.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Acetaminophen 1gr
Intervention Description
fever will be managed with acetaminophen
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Ibuprofen 400 mg
Intervention Description
fever will be managed with ibuprofen
Primary Outcome Measure Information:
Title
Fever
Description
Body temperature, celcius
Time Frame
30.-60.-120. minutes
Secondary Outcome Measure Information:
Title
Heart Rate
Description
Heart rate per minute
Time Frame
30.-60.-120. minutes
Title
Blood Pressure
Description
Systolic and diastolic blood pressure in mmHg
Time Frame
30.-60.-120. minutes
Title
Oxygen saturation
Description
Measured as a percentage through capillary measurement
Time Frame
30.-60.-120. minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Under 80 years of age Willing to participate in the study Diagnosed with sepsis according to the latest current guidelines Having a fever >38°C With no known history of adverse reactions to the active ingredient of the medication to be used" Exclusion Criteria: Under 18 years of age or over 80 years of age Not willing to participate in the study With a known history of adverse reactions to study medications Having a fever <38°C Pregnant individuals Individuals with advanced systemic illness Those with malignancies Patients with chronic liver and kidney disease Using sedative and analgesic neuro-psychiatric drugs With a history of psychological and neurological diseases"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SAFA DÖNMEZ, M.D.
Phone
+90 553 751 55 45
Email
drsafa0131@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
NURULLAH İSHAK IŞIK, M.D.
Phone
+90 553 751 55 45
Email
nurullahishak01@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SAFA DÖNMEZ, M.D.
Organizational Affiliation
Ankara Bilkent City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication in a journal, the research will be shared with interested researchers and the editorial team of the published journal.
IPD Sharing Time Frame
The data can be obtained from the researchers upon request after the research has been published.
IPD Sharing Access Criteria
The editorial team of the journal and other researchers granted permission by the investigators.
Citations:
PubMed Identifier
21880006
Citation
Selladurai S, Eastwood GM, Bailey M, Bellomo R. Paracetamol therapy for septic critically ill patients: a retrospective observational study. Crit Care Resusc. 2011 Sep;13(3):181-6.
Results Reference
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PubMed Identifier
22373120
Citation
Lee BH, Inui D, Suh GY, Kim JY, Kwon JY, Park J, Tada K, Tanaka K, Ietsugu K, Uehara K, Dote K, Tajimi K, Morita K, Matsuo K, Hoshino K, Hosokawa K, Lee KH, Lee KM, Takatori M, Nishimura M, Sanui M, Ito M, Egi M, Honda N, Okayama N, Shime N, Tsuruta R, Nogami S, Yoon SH, Fujitani S, Koh SO, Takeda S, Saito S, Hong SJ, Yamamoto T, Yokoyama T, Yamaguchi T, Nishiyama T, Igarashi T, Kakihana Y, Koh Y; Fever and Antipyretic in Critically ill patients Evaluation (FACE) Study Group. Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study. Crit Care. 2012 Feb 28;16(1):R33. doi: 10.1186/cc11211. Erratum In: Crit Care. 2012;16(1):450.
Results Reference
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PubMed Identifier
28386165
Citation
Ye S, Xu D, Zhang C, Li M, Zhang Y. Effect of Antipyretic Therapy on Mortality in Critically Ill Patients with Sepsis Receiving Mechanical Ventilation Treatment. Can Respir J. 2017;2017:3087505. doi: 10.1155/2017/3087505. Epub 2017 Mar 12.
Results Reference
background
PubMed Identifier
28221185
Citation
Drewry AM, Ablordeppey EA, Murray ET, Stoll CRT, Izadi SR, Dalton CM, Hardi AC, Fowler SA, Fuller BM, Colditz GA. Antipyretic Therapy in Critically Ill Septic Patients: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 May;45(5):806-813. doi: 10.1097/CCM.0000000000002285.
Results Reference
background
PubMed Identifier
9070471
Citation
Bernard GR, Wheeler AP, Russell JA, Schein R, Summer WR, Steinberg KP, Fulkerson WJ, Wright PE, Christman BW, Dupont WD, Higgins SB, Swindell BB. The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group. N Engl J Med. 1997 Mar 27;336(13):912-8. doi: 10.1056/NEJM199703273361303.
Results Reference
background
PubMed Identifier
1935150
Citation
Haupt MT, Jastremski MS, Clemmer TP, Metz CA, Goris GB. Effect of ibuprofen in patients with severe sepsis: a randomized, double-blind, multicenter study. The Ibuprofen Study Group. Crit Care Med. 1991 Nov;19(11):1339-47. doi: 10.1097/00003246-199111000-00006.
Results Reference
background
PubMed Identifier
33224416
Citation
Alaje EO, Udoh EE, Akande PA, Odey FA, Meremikwu MM. Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety. Pan Afr Med J. 2020 Aug 26;36:350. doi: 10.11604/pamj.2020.36.350.21393. eCollection 2020.
Results Reference
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Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients

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