SepsisPhase 4NCT06061575
Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Sepsis and Acetaminophen, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Acetaminophen, Fever
- What is being tested?
- Acetaminophen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2023to 1 Dec 2024
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 >38.3°C
- With no known history of adverse reactions to the active ingredient of the medication to be used"
Who cannot join
- 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 <38.3°C
- Pregnant individuals
- Individuals with advanced systemic illness
Show all 10Show fewer
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients: A Randomized Double-Blind Controlled Study
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.
Read the 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.
- Conditions
- Sepsis, Acetaminophen, Fever, Ibuprofen
- Being tested
- Acetaminophen, Ibuprofen
- Medical subject headings
- Sepsis, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Acetaminophen 1gr
fever will be managed with acetaminophen
IbuprofenDrug
Also called Ibuprofen 400 mg
fever will be managed with ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Other | 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. Receives: Drug: Acetaminophen |
| Ibuprofen | Other | 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. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever
Body temperature, celcius
Measured: 30.-60.-120. minutes
Secondary outcomes (3)
Heart Rate
Heart rate per minute
Measured: 30.-60.-120. minutes
Blood Pressure
Systolic and diastolic blood pressure in mmHg
Measured: 30.-60.-120. minutes
Oxygen saturation
Measured as a percentage through capillary measurement
Measured: 30.-60.-120. minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start31 Oct 2023
- Primary completion31 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Dönmez, Ankara City Hospital Bilkent
- Investigators
- SAFA DÖNMEZ, M.D., Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061575
- Sponsor's protocol ID
- Management of Fever in Sepsis
- Status last verified
- Feb 2025
- First submitted
- 25 Sep 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication in a journal, the research will be shared with interested researchers and the editorial team of the published journal.
Publications
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.
PubMed 21880006Lee 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.
PubMed 22373120Ye 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.
PubMed 28386165Drewry 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.
PubMed 28221185Bernard 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.
PubMed 9070471Haupt 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.
PubMed 1935150Alaje 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.
PubMed 33224416
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients: A Randomized Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT06061575
- Acronym / sponsor ID
- Management of Fever in Sepsis
- Conditions
- Sepsis, Acetaminophen, Fever, Ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 29 Sep 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Other | Drug: AcetaminophenAdult 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. |
| Ibuprofen | Other | Drug: IbuprofenAdult 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 >38.3°C
Key exclusion criteria (10 listed)
- 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 <38.3°C
- Pregnant individuals
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 |
|---|---|---|
| AcetaminophenAlso: Acetaminophen 1grfever will be managed with acetaminophen | Drug | Acetaminophen |
| IbuprofenAlso: Ibuprofen 400 mgfever will be managed with ibuprofen | Drug | Ibuprofen |
Primary outcome
Fever
Time frame: 30.-60.-120. minutes
Body temperature, celcius
3 secondary outcomes
Heart Rate
Time frame: 30.-60.-120. minutes
Blood Pressure
Time frame: 30.-60.-120. minutes
Oxygen saturation
Time frame: 30.-60.-120. minutes
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 4 Feb 2025.
- Background: PubMed 21880006Selladurai 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.
- Background: PubMed 22373120Lee 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.
- Background: PubMed 28386165Ye 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.
- Background: PubMed 28221185Drewry 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.
- Background: PubMed 9070471Bernard 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.
- Background: PubMed 1935150Haupt 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.
- Background: PubMed 33224416Alaje 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.
- Individual participant dataSharing planned: Yes. After publication in a journal, the research will be shared with interested researchers and the editorial team of the published journal.
Related trials for Sepsis
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
SAFA DÖNMEZ, M.D. principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Sepsis and Acetaminophen, run by Ankara City Hospital Bilkent 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 6 inclusion and 10 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 4 Feb 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fever (time frame: 30.-60.-120. minutes). 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 NCT06061575, which also lists 7 linked publications.
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 4 Feb 2025.