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

September 28, 2011
June 12, 2012
June 2011
June 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01443494 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Mean Blood Pressure Titration to Original Level Improve Microcirculation of Septic Patients
Not Provided

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Septic Shock
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Xu J Yuan, doctor 86-025-83272201 yuanye0729@yahoo.com.cn
China
 
NCT01443494
SoutheastUChina2011ZDllKY03
No
Jingyuan,Xu, Southeast University, China
Southeast University, China
Not Provided
Not Provided
Southeast University, China
June 2012

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