The Effect of Midazolam on Fluid Responsiveness in Septic Patients

NCT02050893 | Completed Phase 1 DMC

• 1 other identifier: fluid responsiveness
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid responsiveness has significance in volume resuscitation for septic shock patients. As the sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness for the pharmacological effect of venodilation. However, the hypothesis has not been certified clinically. In this research, the investigators aim to test the hypothesis that Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock patients.

Conditions

Septic Shock

Keywords

septic shock; sepsis; fluid responsiveness; Midazolam; Propofol; haemodynamics

Outcome Measures

Primary Outcomes (1)

• percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation

  Baseline,after sedation

Study Arms (2)

Midazolam

EXPERIMENTAL

Midazolam infused at a 0.03mg/kg loading dose ,and 0.02-0.1mg/kg.h maintenance dose to achieve Ramsay score of 4

Drug: sedatives(Midazolam and Propofol)

Propofol

EXPERIMENTAL

Propofol infuse at a loading dose of 0.5mg/kg，and 0.5-2.0mg/kg.h maintenance dose to achieve Ramsay score of 4

Drug: sedatives(Midazolam and Propofol)

Interventions

sedatives(Midazolam and Propofol) DRUG

Midazolam; Propofol

Eligibility Criteria

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

You may qualify if:

• Above 18 years old
• Endotracheal intubated and mechanical ventilated
• Awake, can communicate with researchers
• Diagnosed as septic shock. The definition of septic shock was clarified in Year 2001 ACCP/SCCM guidelines
• Within 24 hours after the EGDT resuscitation goals are achieved
• Informed consent are signed.

You may not qualify if:

• Under 18 years old
• Intra-abdominal hypertension
• Central nerves system dysfunction
• Heart failure and other cardiac dysfunction such as cardiac conduction block,acute coronary syndrome, cardiogenic shock
• Proof of volume overload or contradiction of fluid infusion
• Existence of arterial aneurysm, serious valvular disease,extensive peripheral vascular occlusion disease and insertion of artificial pacemaker

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Department of Critical Care , Zhong-da Hospital

Nanjing, Jiangsu, (86)210009, China

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of critical care medicine, Zhongda Hospital

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: January 31, 2014
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

CN (1)