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:
Southeast University, China
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 22, 2013