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

NCT06061575 | Completed Phase 4 DMC

• 1 other identifier: Management of Fever in Sepsis
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Acetaminophen; Fever; Ibuprofen

Outcome Measures

Primary Outcomes (1)

• Fever

  Body temperature, celcius

  30.-60.-120. minutes

Secondary Outcomes (3)

• Heart Rate

  30.-60.-120. minutes

• Blood Pressure

  30.-60.-120. minutes

• Oxygen saturation

  30.-60.-120. minutes

Study Arms (2)

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.

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.

Drug: Ibuprofen

Interventions

Acetaminophen DRUG

fever will be managed with acetaminophen

Also known as: Acetaminophen 1gr

Acetaminophen

Ibuprofen DRUG

fever will be managed with ibuprofen

Also known as: Ibuprofen 400 mg

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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
• 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"

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 21880006 BACKGROUND

• 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.

  PMID: 22373120 BACKGROUND

• 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.

  PMID: 28386165 BACKGROUND

• 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.

  PMID: 28221185 BACKGROUND

• 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.

  PMID: 9070471 BACKGROUND

• 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.

  PMID: 1935150 BACKGROUND

• 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.

  PMID: 33224416 BACKGROUND

MeSH Terms

Conditions

Sepsis; Fever

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• SAFA DÖNMEZ, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: October 31, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 1, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data can be obtained from the researchers upon request after the research has been published.
• Access Criteria: The editorial team of the journal and other researchers granted permission by the investigators.

Locations

TU (1)