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Whether a Minimal Volume Could Predict Fluid Responsiveness Using Thermodilution by PAC in Septic Shock Patients

Medical Intensive Care Unit of PUMCH

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04515511
Enrollment
50
Registered
2020-08-17
Start date
2019-07-01
Completion date
2022-09-30
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Therapy, Hemodynamic Instability, Septic Shock

Keywords

Sepsis/Septic shock, Hemodynamic monitor, Fluid challenge, Cardiac output, Pulmonary artery catheter, Thermodilution

Brief summary

Assessment of fluid responsiveness (FR) is to detect whether patient could benefit from fluid therapy. Mini fluid challenge has been widely used in clinical practice to prevent patients from volume overload. In clinical practice, 100 mL or 250 mL have been used most frequently and FR was defined as an increase in CO greater than 10% as much as the changes in CO after infusion of 500 mL. While using a half of volume infusion and assessed by the traditional standard of FR, this might misclassify more patients as nonresponders. In that it is imperative to test the predictive ability of mini fluid and find out the threshold of cutoff value. Meanwhile, in almost mini-FC, cardiac output were measured by echocardiography(VTi) and pulse contour,None of the studies conducted cardiac output (CO)measurement by gold standard method of thermodilution by pulmonary artery catheter (PAC). The correlation between new generated CO measurements and PAC varies in different studies as well. It is imperative to investigate the reliability of mini-FC to predicting fluid responsiveness(FR).The investigator's study is to detect the predictive minimal volume using thermodilution by PAC in septic shock patient.

Detailed description

Fluid therapy is the cornerstone of septic resuscitation. In recent decade, a restrictive fluid strategy has been applied to shock resuscitation for fewer complications and shorter hospital stays compared with a liberal fluid strategy. Therefore, it is a reasonable step to assess the patient's response to fluid infusion to avoid excessive fluid administration.Mini-fluid challenge allows the selection of fluid responders by inducible changes of hemodynamic parameters after changing the preload gaining popularity. The mini fluid challenge was firstly described by Muller et al. in 2011. They found an infusion of 100 mL colloid over 1 minute and the assessment by cardiac output using velocity time integral (VTi) at the aortic outflow tract could predict fluid responsiveness (FR). Since then, a total of seven investigations have been published. Although a mini-fluid challenge may help the decision-making process of fluid management, the investigation results differed from each other, especially in minimal volume and cut off value of hemodynamic parameters change. Meanwhile, we noticed that when measuring CO, the method of thermodilution by pulmonary artery catheter (PAC), which is the gold standard of CO measurement, was not used in these studies. Furthermore, the majority participants of the studies were perioperative patients in a stable hemodynamic state.Therefore, there are two question needed to be answered:what is the minimal infusion volume in effectively predicting fluid responsiveness, and whether mini-volume can perform a real change in septic shock patients. Thus, it is necessary to explore the minimal volume in fluid challenge by PAC and test its reliability in detecting responders (R) and nonresponders (NR).

Interventions

OTHER4% gelatin

Pulmonary artery catheter insertion is prepared before fluid challenge. Baseline hemodynamic value and each time after 5 sequential intravenous boluses of 100 mL colloid are recorded.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosis of septic shock and is required fluid challenge in the presence of invasive hemodynamic monitoring. * Patients with hypotension (SBP \<90 mmHg or MAP \<65 mmHg) * Patients with evidences of tissue hypoperfusion (including but not limited to oliguria, skin mottling, altered mental status, cool peripheries, hyperlactatemia, et al).

Exclusion criteria

* Age less than 18yrs or greater than 80yrs * Shock is diagnosed with other types of shock * Known allergy to colloid fluids * Pregnancy * Recent participation in another biomedical study.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac outputBaseline and immediately after each bolus of 100 mL colloid, average 3 minutesCardiac output measured by therm-dilution of pulmonary artery catheter. An increase in cardiac output(CO) greater than 10% after a volume expansion of 500 mL is defined as fluid responsiveness(FR).

Secondary

MeasureTime frameDescription
Carbon dioxide partial pressureBaseline and immediately after each bolus of 100 mL colloid, average 3 minutesPCO2 can be obtained directly from blood gas. It is considered as alternative markers of tissue hypoperfusion and attempted to be used to guide treatment for shock.
HemoglobinBaseline and immediately after each bolus of 100 mL colloid, average 3 minutesHemoglobin will be diluted during fluid challenge and it is also an important index to guide fluid resuscitation by improving extraction of oxygen and optimizing oxygen delivery.
Oxygen saturationBaseline and immediately after each bolus of 100 mL colloid, average 3 minutesOxygen saturation can be obtained directly from blood gas include which reflects extraction of oxygen and assess whether CO is sufficient enough to meet patient's enough.
Mean arterial pressureBaseline and immediately after each bolus of 100 mL colloid, average 1 minutesMean arterial pressure is monitored to assess the effect of the fluid challenge
Central venous pressureBaseline and immediately after each bolus of 100 mL colloid, average 1 minutesCentral venous pressure is monitored to assess the preload status and effect of the fluid challenge
Heart rateBaseline and immediately after each bolus of 100 mL colloid, average 1 minutesHeart rate is monitored to assess the effect of the fluid challenge

Countries

China

Contacts

Primary ContactLi Weng, Professor
wengli@gmail.com+8618600017819
Backup ContactDu Bin, Professor
dubin98@gmail.com+8615601348897

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026