Septic Shock
Conditions
Keywords
septic shock, microcirculation, norepinephrine, fluid
Brief summary
We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.
Detailed description
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.
Interventions
OTHERNE
norepinephine
Sponsors
Southeast University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | Target MAP stabilization for 30 min | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perfused Vessel Density | Target MAP stabilization for 30 min | 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 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Septic Shock Patients Despite EGDT With Hypertension |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment China | 19 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Septic Shock Patients Despite EGDT | Mean Arterial Pressure | 90 mmHg | Standard Deviation 7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Septic Shock Patients Despite EGDT | Perfused Vessel Density | 12.08 vessels/mm^2 | Standard Deviation 2.52 |