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The Effect of Midazolam on Fluid Responsiveness in Septic Patients

NCT ID: NCT02050893

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Shock

Keywords

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septic shock sepsis fluid responsiveness Midazolam Propofol haemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Midazolam

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

Group Type EXPERIMENTAL

sedatives(Midazolam and Propofol)

Intervention Type DRUG

Propofol

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

Group Type EXPERIMENTAL

sedatives(Midazolam and Propofol)

Intervention Type DRUG

Interventions

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sedatives(Midazolam and Propofol)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Jianfeng Xie

Department of critical care medicine, Zhongda Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Critical Care , Zhong-da Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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fluid responsiveness

Identifier Type: -

Identifier Source: org_study_id