Control of Fever in Septic Patients

NCT04227652 | Completed

• 2 other identifiers: FNO-KARIM-13-COVERSEPRVO-FNOs/2013-2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The benefits of fever treatment in critically ill patients remains unclear. The aim of the prospective, randomized clinical trial was to verify the hypothesis that the administration of ibuprofen in order to decrease the fever in septic patients without limited cardiorespiratory reserve leads to decreasing their prognosis.

Conditions

Sepsis; Severe Sepsis; Septic Shock

Keywords

sepsis; severe sepsis; septic shock; fever; ibuprofen; physiological reserves

Outcome Measures

Primary Outcomes (1)

• SOFA score value

  The SOFA score (Sequential Organ Failure Assessment) was measured on Day 3 and Day 7

  up to 7 days

Secondary Outcomes (8)

• Serum interleukin-6 level

  up to 7 days

• Serum procalcitonine level

  up to 7 days

• Serum lactate level

  up to 7 days

• Central venous oxygen saturation

  up to 7 days

• Duration of artificial ventilation

  1 month

Study Arms (2)

Aggressive treatment strategy

EXPERIMENTAL

The antipyretic strategy was initiated immediately upon increase of the temperature above 38.3°C. The antipyretic strategy consisted of administration of ibuprofen (per-orally or into the nasogastric tube, or rectal administration in the form of a suppository) in therapeutical dose, alway supplemented with physical cooling in cases when the temperature exceeded 39.5°C. The body temperature was measured in the urinary bladder.

Drug: Ibuprofen administration

Conservative treatment strategy

EXPERIMENTAL

The antipyretic strategy was initiated only after the body temperature exceeded 39.5°C. The antipyretic strategy consisted of administration of ibuprofen (per-orally or into the nasogastric tube, or rectal administration in the form of a suppository) in therapeutical dose, alway supplemented with physical cooling in cases when the temperature exceeded 39.5°C. The body temperature was measured in the urinary bladder.

Drug: Ibuprofen administration

Interventions

Ibuprofen administration DRUG

Administration of ibuprofen, according to treatment recommendations - per orally, into the nasogastric tube, or in the form of a suppository

Aggressive treatment strategy; Conservative treatment strategy

Eligibility Criteria

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

You may qualify if:

• age \>18 years of age
• body temperature \>38.3°C within 2 consecutive hours
• anti-microbial therapy for a known or suspected infection

You may not qualify if:

• patients admitted after successful cardiopulmonary resuscitation (CPR)
• acute myocardial infarction
• brain injury (traumatic and non-traumatic)
• transfer from another ICU after 72 hours
• pregnancy
• antipyretic medication prior to randomization
• non-obtaining the informed consent
• moribund condition
• high risk of hemodynamic or respiratory maladaptation on the metabolic effect of fever

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (4)

• Schulman CI, Namias N, Doherty J, Manning RJ, Li P, Elhaddad A, Lasko D, Amortegui J, Dy CJ, Dlugasch L, Baracco G, Cohn SM. The effect of antipyretic therapy upon outcomes in critically ill patients: a randomized, prospective study. Surg Infect (Larchmt). 2005 Winter;6(4):369-75. doi: 10.1089/sur.2005.6.369.

  PMID: 16433601 BACKGROUND

• Young P, Saxena M, Bellomo R, Freebairn R, Hammond N, van Haren F, Holliday M, Henderson S, Mackle D, McArthur C, McGuinness S, Myburgh J, Weatherall M, Webb S, Beasley R; HEAT Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group. Acetaminophen for Fever in Critically Ill Patients with Suspected Infection. N Engl J Med. 2015 Dec 3;373(23):2215-24. doi: 10.1056/NEJMoa1508375. Epub 2015 Oct 5.

  PMID: 26436473 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

• 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

MeSH Terms

Conditions

Sepsis; Shock, Septic; Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• Roman Kula, MD,CSc.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was used in the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects were enrolled in two parallel groups.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 13, 2020
• Study Start: September 3, 2013
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)