Fluid Challenge, Fluid Responsiveness, Hypotension, Shock
Conditions
Brief summary
Fluid challenge is often carried out in critical ill patients. Its responsiveness usually requires invasive monitoring. To use non-invasive methods is very tempting. Investigators hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations provide feasible estimation on fluid responsiveness in critical ill patients.
Interventions
OTHERfluid challenge
A bag of 500ml of normal saline or 4% gelatin (Gelofusine, B. Braun Medical (Suzhou) Company Limited, Suzhou, China) is infused within 15 minutes using a bag pressurized to 300 mmHg. All other treatments, including maintenance fluids, dose of vasoactive agents and ventilator settings, remain unchanged during the study period.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older ICU patients; * Septic shock; * Monitored with PICCO or Swan-Ganz catheter; * The decision of fluid challenge made by the treating physician;
Exclusion criteria
* Evidence of fluid overload; * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid Responsiveness | Immediately after fluid challenge, average 5 minutes | Increase in cardiac index ≥ 10% after fluid challenge |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Septic Shock Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Septic Shock |
|---|---|
| acute physiology and chronic health evaluation(APACHE) II score | 27 units on a scale STANDARD_DEVIATION 6 |
| Age, Continuous | 60 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Fluid Responsiveness
Increase in cardiac index ≥ 10% after fluid challenge
Time frame: Immediately after fluid challenge, average 5 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Septic Shock | Fluid Responsiveness | 18 Participants |