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

September 28, 2011
June 13, 2014
June 2011
June 2012   (final data collection date for primary outcome measure)
Mean Arterial Pressure [ Time Frame: Target MAP stabilization for 30 min ] [ Designated as safety issue: Yes ]

As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.

After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.

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
Complete list of historical versions of study NCT01443494 on ClinicalTrials.gov Archive Site
Perfused Vessel Density [ Time Frame: Target MAP stabilization for 30 min ] [ Designated as safety issue: Yes ]
Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by SDF, including the parameters of perfused vessel density
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
Not Provided
Not Provided
 
High MAP in Septic Shock With Hypertension
High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension

We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

The effect of mean arterial pressure (MAP) titration to higher level on microcirculation in septic shock patients with previous hypertension remains unknown. Our goal was to assess the effect of MAP titration to patients' usual level on microcirculation in septic shock patients with previous hypertension. We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Septic Shock
Other: NE
norepinephine
Experimental: NE group
Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.
Intervention: Other: NE

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with septic shock for less than 24 hours
  • Fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous oxygen saturation for more than 70%
  • Patients requiring norepinephrine (NE) to maintain a MAP of 65 mm Hg. Septic shock patients with fluid resuscitation after CVP > 8mmHg and mean blood pressure > 65 mmHg

Exclusion Criteria:

  • Pregnancy
  • Age < 18 years
  • Inability to acquire the usual level of MAP
  • Refusal of consent by the patient or relative
  • Participation in other trials during the last three months
  • Hypertensive patients without hypertension treatment
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01443494
SoutheastUChina2011ZDllKY03.0
No
Jingyuan,Xu, Southeast University, China
Southeast University, China
Not Provided
Study Director: Haibo Qiu, MD,PhD Southeast University
Southeast University, China
June 2014

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