An interventional study of NE in Septic Shock, sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment
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.
864 studies on the registry are indexed under Shock, Septic; 209 are open to participants now.
This study's enrollment of 19 is below the median of 79 across 531 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.
Other: NE
norepinephine
Mean Arterial Pressure
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.
Time frame: Target MAP stabilization for 30 min
Perfused Vessel Density
Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density
Time frame: Target MAP stabilization for 30 min
| Milestone | Septic Shock Patients Despite EGDT With Hypertension |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
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.
| mmHg | Septic Shock Patients Despite EGDT |
|---|---|
| Mean Arterial Pressure | 90 ± 7 |
Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density
| vessels/mm^2 | Septic Shock Patients Despite EGDT |
|---|---|
| Perfused Vessel Density | 12.08 ± 2.52 |
Collected over During the study procedure for about 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Septic Shock Patients Despite EGDT | — | 0/19 (0%) | 0/19 (0%) |
Detailed enquiry about the target MAP to their next kin was performed in all of the patients.
| Age, Categorical(Participants) | Septic Shock Patients Despite EGDT With Hypertension |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 14 |
| Sex: Female, Male(Participants) | Septic Shock Patients Despite EGDT With Hypertension |
|---|---|
| Female | 6 |
| Male | 13 |
| Region of Enrollment(participants) | Septic Shock Patients Despite EGDT With Hypertension |
|---|---|
| China | 19 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Southeast University, China