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

Medical Intensive Care Unit of PUMCH

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock; Fluid Therapy; Hemodynamic Instability
• Intervention / Treatment: Other: 4% gelatin

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).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100102
      • Recruiting
      • Li Weng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: standard care; 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.

Other: 4% 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.; Other Names: Pulmonary artery catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
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.	Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
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.	Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Heart rate	Heart rate is monitored to assess the effect of the fluid challenge	Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Mean arterial pressure	Mean arterial pressure is monitored to assess the effect of the fluid challenge	Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Central venous pressure	Central venous pressure is monitored to assess the preload status and effect of the fluid challenge	Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): August 1, 2020
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (ACTUAL): August 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac output; Thermodilution; Fluid challenge; Sepsis/Septic shock; Hemodynamic monitor; Pulmonary artery catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: PUMCH fc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In our department, we has done a serial clinical studies of fluid challenge, we will do retrospective study first.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No