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High MAP in Septic Shock With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01443494
First received: September 28, 2011
Last updated: June 13, 2014
Last verified: June 2014
Results First Received: February 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Septic Shock
Intervention: Other: NE

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Septic Shock Patients Despite EGDT With Hypertension Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.

Participant Flow:   Overall Study
    Septic Shock Patients Despite EGDT With Hypertension  
STARTED     19  
COMPLETED     19  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Detailed enquiry about the target MAP to their next kin was performed in all of the patients.

Reporting Groups
  Description
Septic Shock Patients Despite EGDT With Hypertension Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.

Baseline Measures
    Septic Shock Patients Despite EGDT With Hypertension  
Number of Participants  
[units: participants]
  19  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     14  
Gender  
[units: participants]
 
Female     6  
Male     13  
Region of Enrollment  
[units: participants]
 
China     19  



  Outcome Measures
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1.  Primary:   Mean Arterial Pressure   [ Time Frame: Target MAP stabilization for 30 min ]

2.  Secondary:   Perfused Vessel Density   [ Time Frame: Target MAP stabilization for 30 min ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Firstly, cardiac output was monitored by NICOM system to minimize the invasive operation.

Secondly, the number of patients enrolled in the study was relatively small. Next, immediate changes of the increase in MAP were investigated.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jingyuan Xu
Organization: Intensive Care Unit, Zhongda Hospital, Southeast University
phone: 86-025-83262550
e-mail: xujingyuanmail@163.com


Publications:


Responsible Party: Jingyuan,Xu, Southeast University, China
ClinicalTrials.gov Identifier: NCT01443494     History of Changes
Other Study ID Numbers: SoutheastUChina2011ZDllKY03.0
Study First Received: September 28, 2011
Results First Received: February 27, 2014
Last Updated: June 13, 2014
Health Authority: China: Ethics Committee