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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05957302
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ketamine; Fentanyl; Septic Shock	Drug: Ketamine; Drug: Fentanyl	N/A

Detailed Description

Patients meeting the inclusion criteria will receive the study drug according to the randomization, if a bolus of sedation is required for resuming sedation after sedation vacation. All patients will be monitored by 5-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure.

Hypotension defined as mean arterial pressure < 65 mmHg and will be managed by increasing the norepinephrine infusion rate by 20%.

Bedside echocardiography will be used to measure the cardiac output by an experienced physician who is not aware of the nature of the study drug. The left ventricular outflow diameter (LVOT) will be measured in the parasternal long-axis view. Then velocity time integral (VTI) will be measured from the apical five-chamber view. The average of three VTI readings will be calculated.

The cardiac output will be calculated by the equation:

CO = π X (LVOT diameter/2) X VTI X heart rate Delta CO% will be calculated as percentage of change at each time point in relation to the baseline measurement the CO, heart rate, mean blood pressure will be measured before drug administration and at 3, 6, 10 and 15 min after drug administration

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Comparing the Hemodynamic Effects of Bolus of Ketamine and Fentanyl in Patients With Septic Shock: a Randomized Controlled Trial
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketamine group bolus of sedation for resuming sedation after sedation vacation	Drug: Ketamine; 100 mg of ketamine diluted in 10 mL saline (10 mg /mL) and patient will receive 0.1 mL/kg
Active Comparator: Fentanyl group bolus of sedation for resuming sedation after sedation vacation	Drug: Fentanyl; 100 mcg of fentanyl diluted in 10 mL saline (10 mcg /mL) and patient will receive 0.1 mL/kg

Outcome Measures

Primary Outcome Measures

1. 6-minutes Delta CO% [at 6 minutes after drug administration]

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

Secondary Outcome Measures

1. Delta CO% [3, 6, 10 and 15 minutes after drug administration]

   percentage of change at each time point after drug administration in relation to the baseline measurement

2. heart rate [3, 6, 10 and 15 minutes after drug administration]

   beat per minute

3. mean blood pressure [3, 6, 10 and 15 minutes after drug administration]

   mmHg

4. norepinephrine dose [3, 6, 10 and 15 minutes after drug administration]

   mcg/kg/min

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult (>18 years) patients.

• With septic shock on vasopressor therapy

• Mechanically ventilated

• Need for sedation

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Mohamed Hasanin	Cairo		Egypt	11432

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: ahmed hasanin, MD, Cairo University Kasr Alainy Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Hasanin, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT05957302
• Other Study ID Numbers: MS-47-2023
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shock, Septic; Shock; Fentanyl; Ketamine

Study Results

No Results Posted as of Jul 24, 2023