search
Back to results

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

Primary Purpose

Septic Shock, Hemodynamic Instability, Fluid Therapy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
4% gelatin
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Septic Shock focused on measuring Sepsis/Septic shock, Hemodynamic monitor, Fluid challenge, Cardiac output, Pulmonary artery catheter, Thermodilution

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Li WengRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

standard care

Arm Description

ICU septic shock patients with refractory hypotension with indwelling pulmonary artery catheter received five sequential intravenous boluses of 100 mL 4% gelatin. Cardiac output measured by thermodilution of PAC before fluid challenge (baseline) and three minutes after each bolus. Fluid responsiveness (FR) was defined as an increase in CO greater than 10% after 500 mL fluid infusion. The smallest volume which can perform an effective fluid challenge was analyzed.

Outcomes

Primary Outcome Measures

Cardiac output
Cardiac 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 Outcome Measures

Oxygen saturation
Oxygen 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.
Carbon dioxide partial pressure
PCO2 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.
Hemoglobin
Hemoglobin 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.
Heart rate
Heart rate is monitored to assess the effect of the fluid challenge
Mean arterial pressure
Mean arterial pressure is monitored to assess the effect of the fluid challenge
Central venous pressure
Central venous pressure is monitored to assess the preload status and effect of the fluid challenge

Full Information

First Posted
August 10, 2020
Last Updated
September 1, 2020
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04515511
Brief Title
Whether a Minimal Volume Could Predict Fluid Responsiveness Using Thermodilution by PAC in Septic Shock Patients
Official Title
Medical Intensive Care Unit of PUMCH
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Hemodynamic Instability, Fluid Therapy
Keywords
Sepsis/Septic shock, Hemodynamic monitor, Fluid challenge, Cardiac output, Pulmonary artery catheter, Thermodilution

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard care
Arm Type
Experimental
Arm Description
ICU septic shock patients with refractory hypotension with indwelling pulmonary artery catheter received five sequential intravenous boluses of 100 mL 4% gelatin. Cardiac output measured by thermodilution of PAC before fluid challenge (baseline) and three minutes after each bolus. Fluid responsiveness (FR) was defined as an increase in CO greater than 10% after 500 mL fluid infusion. The smallest volume which can perform an effective fluid challenge was analyzed.
Intervention Type
Other
Intervention Name(s)
4% gelatin
Other Intervention Name(s)
Pulmonary artery catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac output
Description
Cardiac 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).
Time Frame
Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
Oxygen 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.
Time Frame
Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Title
Carbon dioxide partial pressure
Description
PCO2 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.
Time Frame
Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Title
Hemoglobin
Description
Hemoglobin 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.
Time Frame
Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Title
Heart rate
Description
Heart rate is monitored to assess the effect of the fluid challenge
Time Frame
Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Title
Mean arterial pressure
Description
Mean arterial pressure is monitored to assess the effect of the fluid challenge
Time Frame
Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Title
Central venous pressure
Description
Central venous pressure is monitored to assess the preload status and effect of the fluid challenge
Time Frame
Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Weng, Professor
Phone
+8618600017819
Email
wengli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Du Bin, Professor
Phone
+8615601348897
Email
dubin98@gmail.com
Facility Information:
Facility Name
Li Weng
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Weng, professor
Phone
15601348897
Email
wengli@gmail.com
First Name & Middle Initial & Last Name & Degree
Bin Du, professor
Phone
+8618600017819
Email
dubin98@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In our department, we has done a serial clinical studies of fluid challenge, we will do retrospective study first.
Citations:
PubMed Identifier
34935687
Citation
Yang T, Weng L, Jiang W, Li S, Du B. Hemodynamic effects of different fluid volumes for a fluid challenge in septic shock patients. Chin Med J (Engl). 2022 Mar 20;135(6):672-680. doi: 10.1097/CM9.0000000000001919. Erratum In: Chin Med J (Engl). 2022 Apr 20;135(8):i.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs