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
  Purpose

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


Condition Intervention
Septic Shock
Drug: Fluid in combination with NE
Drug: Nonrespons
Drug: NE

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

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: Nonrespons
After passive leg rasing predicting the 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
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
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
No Intervention: Controls
Other types of early shock and health volunteers as controls

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443494

Contacts
Contact: Xu J Yuan, doctor 86-025-83272201 yuanye0729@yahoo.com.cn

Locations
China, Jiangsu
Zhongda Hospital Southeast University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Haibo Qiu    86-025-83272201    southeasticu@yahoo.com.cn   
Sponsors and Collaborators
Southeast University, China
  More Information

No publications provided

Responsible Party: Jingyuan,Xu, ZhongDa Hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT01443494     History of Changes
Other Study ID Numbers: SoutheastUChina2011ZDllKY03
Study First Received: September 28, 2011
Last Updated: June 12, 2012
Health Authority: China: Ethics Committee

Keywords provided by Southeast University, China:
microcirculation

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014