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The Effect of Midazolam on Fluid Responsiveness in Septic Patients

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02050893
Enrollment
40
Registered
2014-01-31
Start date
2012-05-31
Completion date
2013-04-30
Last updated
2014-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

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

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.

Interventions

DRUGsedatives(Midazolam and Propofol)

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedationBaseline,after sedation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026