Mean Blood Pressure Titration to Original Level Improve Microcirculation of Septic Patients

This study is currently recruiting participants.

Verified June 2012 by Southeast University, China

Sponsor:

Information provided by (Responsible Party):

Jingyuan,Xu, Southeast University, China

ClinicalTrials.gov Identifier:

NCT01443494

First received: September 28, 2011

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2011

Last Updated Date

June 12, 2012

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean blood pressure reach the original one [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Different ways(adequte fluid resuscitation or less fluid resuscitation in combination with norepinephrine) to titrate mean blood pressure to original level before shock

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01443494 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Microcirculation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Different ways to titrate mean blood pressure to original level before shock and observe the change of microcirculation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Mean Blood Pressure Titration to Original Level Improve Microcirculation of Septic Patients

Official Title ^ICMJE

Not Provided

Brief Summary

Our hypothesis is titrating mean blood pressure by different means to original level before shock might improve microcirculation of septic patients.

Detailed Description

Septic shock is a major cause of death in critically ill patients which characterized by vasodilation and hypotension. Early goal-directed therapy may improve prognosis of patients with septic shock, however, experimental models and clinical trials of resuscitated septic shock show that microcirculatory perfusion is altered despite the normalization of systemic hemodynamics, which may be associated with inadequate fluid. We hypothesized that compared to titration MAP to original level before shock with norepinephrine and less fluid, the microcirculation of septic shock improved after adequate fluid resuscitation in combination norepinephrine.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Septic Shock

Intervention ^ICMJE

Drug: Fluid in combination with NE
After passive leg rasing predicting the positive fluid responsiveness and PtcO2 was measured, adequate fluid management was administered until reaching negative fluid responsiveness,norepinephrine was infused to titrate mean blood pressure to the original level before shock
Drug: Nonrespons
After passive leg rasing predicting the negative fluid responsiveness and PtcO2 was measured, norepinephrine was infused to titrate mean blood pressure to the original level before shock
Drug: NE
After passive leg rasing predicting the positive fluid responsiveness and PtcO2 was measured, norepinephrine was infused to titrate mean blood pressure to the original level before shock

Study Arm (s)

Experimental: NE
After passive leg rasing predicting the positive fluid responsiveness and PtcO2 was measured, fluid management was administered and norepinephrine was infused to titrate mean blood pressure to the original level before shock

Intervention: Drug: NE
Experimental: Nonrespons
After passive leg rasing predicting the negative fluid responsiveness, norepinephrine was infused to titrate mean blood pressure to the original level before shock

Intervention: Drug: Nonrespons
Experimental: Fluid in combination with NE
After passive leg rasing predicting the positive fluid responsiveness and PtcO2 was measured, adequate fluid management was administered until reaching negative fluid responsiveness,norepinephrine was infused to titrate mean blood pressure to the original level before shock

Intervention: Drug: Fluid in combination with NE
No Intervention: Controls
Other types of early shock and health volunteers as controls

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Septic shock patients with fluid resuscitation after CVP > 8mmHg and mean blood pressure > 65 mmHg

Exclusion Criteria:

Less than 18-year-old
Pregnancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Xu J Yuan, doctor

86-025-83272201

yuanye0729@yahoo.com.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01443494

Other Study ID Numbers ^ICMJE

SoutheastUChina2011ZDllKY03

Has Data Monitoring Committee

Responsible Party

Jingyuan,Xu, Southeast University, China

Study Sponsor ^ICMJE

Southeast University, China

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Southeast University, China

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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