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NCT Number: NCT02050893

The Effect of Midazolam on Fluid Responsiveness in Septic Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Critical Care , Zhong-da Hospital

Nanjing, Jiangsu, (86)210009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients are included if they meet the following inclusion criteria:

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

sedatives(Midazolam and Propofol)

Drug

Primary outcomes

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

    Time frame: Baseline,after sedation

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 31, 2014
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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