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High MAP in Septic Shock With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01443494
First Posted: September 29, 2011
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China
Results First Submitted: February 27, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5  26.3% 
>=65 years      14  73.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  31.6% 
Male      13  68.4% 
Region of Enrollment 
[Units: Participants]
 
China   19 


  Outcome Measures
  Show All Outcome Measures

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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jingyuan,Xu, Southeast University, China
ClinicalTrials.gov Identifier: NCT01443494     History of Changes
Other Study ID Numbers: SoutheastUChina2011ZDllKY03.0
First Submitted: September 28, 2011
First Posted: September 29, 2011
Results First Submitted: February 27, 2014
Results First Posted: June 16, 2014
Last Update Posted: July 6, 2017