Heamodynamic Effects of Paracetamol in Septic Shock Patients

NCT06076980 | Completed Phase 4 DMC

• 1 other identifier: paracetamol in septic shock
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock is defined as sepsis that has circulatory, cellular, and metabolic abnormalities that are associated with a greater risk of mortality than sepsis alone. Clinically, this includes patients who fulfill the criteria for sepsis who, despite adequate fluid resuscitation, require vasopressors to maintain a mean arterial pressure ≥65 mmHg and have a lactate \>2 mmol/L (\>18 mg/dL). Feve is a common sign of infection in septic shock critically ill patients. Many critically ill patients experience pain. Paracetamol is considered safe and currently one of the most common antipyretics and used as part of multimodal analgesia for acute pain in the intensive care unit. According to the company's product information leaflet, the rate of hypotension complicating intravenous paracetamol treatment ranges from 0.01 to 0.1%. However, recent studies reported a much higher incidence and may be harmful in critically ill adults. The hemodynamic effects of intravenous (IV) paracetamol are unknown in septic shock patients, that the most vulnerable population and hemodynamically unstable. The aim of this study is to assess the incidence of hypotension of the extended intravenous paracetamol (acetaminophen) infusion over three hours in comparing with intravenous paracetamol bolus over 15 minutes in hemodynamically unstable patients (septic shock).

Conditions

Septic Shock; Sepsis

Keywords

acetaminophen; paracetamol; septic shock; hemodynamic effects; blood pressure; icu

Outcome Measures

Primary Outcomes (1)

• The incidence of hypotension .

  defined as a decrease in SBP ≥ 20٪ from baseline, by extended infusion of intravenous paracetamol

  pre intervention and six hours after the intervantion

Secondary Outcomes (7)

• The changes in hemodynamic parameters

  pre intervention and six hours after the intervantion

• The changes in hemodynamic parameters

  pre intervention and six hours after the intervantion

• The changes in hemodynamic parameters

  pre intervention and six hours after the intervantion

• The changes in hemodynamic parameters

  pre intervention and six hours after the intervantion

• The changes in temperature

  pre intervention and six hours after the intervantion

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

placebo group (100 ml normal saline over 15 minutes)

Drug: Normal saline

bolus group

EXPERIMENTAL

bolus group (1000mg/100 ml paracetamol over 15 minutes)

Drug: Paracetamol

Extended infusion group

EXPERIMENTAL

Extended infusion (1000mg/100 ml paracetamol over 3 hours)

Drug: Paracetamol

Interventions

Paracetamol DRUG

compare the hemodynamic parameters of paracetamol as bolus versus extended infusion

Also known as: acetaminophen

Extended infusion group; bolus group

Normal saline DRUG

as placebo

Placebo group

Eligibility Criteria

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

You may qualify if:

• Age adult ≥ 18 years old.
• The patient fulfills the criteria of septic shock definition:
• Sepsis needs vasopressor therapy.
• Serum lactate level greater than 2 mmol/l (SSC 2016).
• Patient with contractility greater than 40%

You may not qualify if:

• paracetamol hypersensitivity or allergy.
• Acute liver injury or failure
• Childs-Pugh C liver disease
• Heat stroke.
• Malignant hyperthermia.
• Neuroleptic Malignant Syndrome.
• Continous renal replacement therapy.
• Ventricular assist device.
• Around-the-clock scheduled of acetaminophen-containing medications administration or non-steroidal anti-inflammatory drugs.
• Pregnancy/lactation.

Sponsors & Collaborators

• Ayah Mohammed Khalil: lead

Study Sites (1)

Cairo University hospitals

Cairo, 11725, Egypt

Location

Related Publications (1)

• Maxwell EN, Johnson B, Cammilleri J, Ferreira JA. Intravenous Acetaminophen-Induced Hypotension: A Review of the Current Literature. Ann Pharmacother. 2019 Oct;53(10):1033-1041. doi: 10.1177/1060028019849716. Epub 2019 May 3.

  PMID: 31046402 BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Senior clinical pharmacist in Department of Clinical Pharmacy, Cairo University Hospitals (Kasr alainy), Cairo, Egypt.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: January 24, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)