The Effect of Midazolam on Fluid Responsiveness in Septic Patients

Septic Shock Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050893
• Other study ID #: fluid responsiveness
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 5, 2013
• Last updated: January 30, 2014
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Patients are included if they meet the following inclusion criteria:

1. Above 18 years old

2. Endotracheal intubated and mechanical ventilated

3. Awake, can communicate with researchers

4. Diagnosed as septic shock. The definition of septic shock was clarified in Year 2001 ACCP/SCCM guidelines

5. Within 24 hours after the EGDT resuscitation goals are achieved

6. Informed consent are signed.

Exclusion Criteria

1. Under 18 years old

2. Intra-abdominal hypertension

3. Central nerves system dysfunction

4. Heart failure and other cardiac dysfunction such as cardiac conduction block,acute coronary syndrome, cardiogenic shock

5. Proof of volume overload or contradiction of fluid infusion

6. Existence of arterial aneurysm, serious valvular disease,extensive peripheral vascular occlusion disease and insertion of artificial pacemaker

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Drug:
• sedatives(Midazolam and Propofol)

Locations

Country	Name	City	State
China	Department of Critical Care , Zhong-da Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation		Baseline,after sedation	Yes