Heamodynamic Effects of Paracetamol in Septic Shock Patients

• Status: Completed
• Trial end date: 2023-01-24
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ayah Mohammed Khalil
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

1. Age adult ≥ 18 years old.

2. The patient fulfills the criteria of septic shock definition:

• Sepsis needs vasopressor therapy.

• Serum lactate level greater than 2 mmol/l (SSC 2016).

3. Patient with contractility greater than 40%

Exclusion Criteria:

1. paracetamol hypersensitivity or allergy.

2. Acute liver injury or failure

3. Childs-Pugh C liver disease

4. Heat stroke.

5. Malignant hyperthermia.

6. Neuroleptic Malignant Syndrome.

7. Continous renal replacement therapy.

8. Ventricular assist device.

9. Around-the-clock scheduled of acetaminophen-containing medications administration or non-steroidal anti-inflammatory drugs.

10. Pregnancy/lactation.