Hemodynamic Effects of Bolus of Ketamine Versus Fentanyl in Patients With Septic Shock

NCT05957302 | Completed

• 1 other identifier: MS-47-2023
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Ketamine is a commonly used drug for sedation and induction of anesthesia in patients with shock and/or cardiac dysfunction. Ketamine is characterized by its cardiovascular stimulatory effect due to increase release of endogenous catecholamines. On the other hand, laboratory data on the isolated human myofibers suggest that ketamine had a direct myocardial depressive effect; accordingly, many experts believe that ketamine might have a negative hemodynamic effect in catecholamine depleted patients such as critically ill patients. In critically ill patients, there are contradicting results for the effect of ketamine on the hemodynamic profile and there is paucity of clinical data about the effect of ketamine on cardiac contractility and cardiac output (CO). Cardiac output is the primary determinant of global oxygen delivery to organs and maintaining stable CO in critically ill patients is at most importance to avoid further organ damage in such patients. Therefore, this study is designed to evaluate the effect a single bolus of ketamine on CO in patients with septic shock in comparison to fentanyl bolus.

Conditions

Ketamine; Fentanyl; Septic Shock

Outcome Measures

Primary Outcomes (1)

• 6-minutes Delta CO%

  percentage of change at 6 min after drug administration in relation to the baseline measurement

  at 6 minutes after drug administration

Secondary Outcomes (4)

• Delta CO%

  3, 6, 10 and 15 minutes after drug administration

• heart rate

  3, 6, 10 and 15 minutes after drug administration

• mean blood pressure

  3, 6, 10 and 15 minutes after drug administration

• norepinephrine dose

  3, 6, 10 and 15 minutes after drug administration

Study Arms (2)

Ketamine group

ACTIVE COMPARATOR

bolus of sedation for resuming sedation after sedation vacation

Drug: Ketamine

Fentanyl group

ACTIVE COMPARATOR

bolus of sedation for resuming sedation after sedation vacation

Drug: Fentanyl

Interventions

Ketamine DRUG

100 mg of ketamine diluted in 10 mL saline (10 mg /mL) and patient will receive 0.1 mL/kg

Ketamine group

Fentanyl DRUG

100 mcg of fentanyl diluted in 10 mL saline (10 mcg /mL) and patient will receive 0.1 mL/kg

Fentanyl group

Eligibility Criteria

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

You may qualify if:

• Adult (\>18 years) patients.
• With septic shock on vasopressor therapy
• Mechanically ventilated
• Need for sedation

You may not qualify if:

• Hemodynamic instability (MAP \<65 mmHg) despite appropriate volume replacement and vasopressor therapy
• Noradrenaline infusion rate \<0.05 mcg/kg/min
• Poor cardiac window on the ultrasound.
• Known allergy to study drugs
• Neurocritical patients with signs of increased intracranial tension

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

Location

Related Publications (1)

• Mostafa M, Hasanin A, Reda B, Elsayad M, Zayed M, Abdelfatah ME. Comparing the hemodynamic effects of ketamine versus fentanyl bolus in patients with septic shock: a randomized controlled trial. J Anesth. 2024 Dec;38(6):756-764. doi: 10.1007/s00540-024-03383-9. Epub 2024 Aug 18.

  PMID: 39154316 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ahmed hasanin, MD

  Cairo University Kasr Alainy Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: August 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)