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

• ClinicalTrials.gov Identifier: NCT04515511
• Recruitment Status: Recruiting
• First Posted: August 17, 2020
• Last Update Posted: September 3, 2020
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Peking Union Medical College Hospital

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.

Condition or disease	Intervention/treatment	Phase
Septic Shock; Hemodynamic Instability; Fluid Therapy	Other: 4% gelatin	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Medical Intensive Care Unit of PUMCH
• Actual Study Start Date: July 1, 2019
• Actual Primary Completion Date: August 1, 2020
• Estimated Study Completion Date: September 2022

Arms and Interventions

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 Name: Pulmonary artery catheter

Outcome Measures

Primary Outcome Measures :

1. Cardiac output [ Time Frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes ]
   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 :

1. Oxygen saturation [ Time Frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes ]
   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.
2. Carbon dioxide partial pressure [ Time Frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes ]
   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.
3. Hemoglobin [ Time Frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes ]
   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.
4. Heart rate [ Time Frame: Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes ]
   Heart rate is monitored to assess the effect of the fluid challenge
5. Mean arterial pressure [ Time Frame: Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes ]
   Mean arterial pressure is monitored to assess the effect of the fluid challenge
6. Central venous pressure [ Time Frame: Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes ]
   Central venous pressure is monitored to assess the preload status and effect of the fluid challenge

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Li Weng, Professor; +8618600017819; wengli@gmail.com

Contact: Du Bin, Professor; +8615601348897; dubin98@gmail.com

Locations

China, Beijing

Li Weng; Recruiting

Beijing, Beijing, China, 100102

Contact: Li Weng, professor 15601348897 wengli@gmail.com

Contact: Bin Du, professor +8618600017819 dubin98@gmail.com

Sponsors and Collaborators

Peking Union Medical College Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). 2021 Dec 22. doi: 10.1097/CM9.0000000000001919. [Epub ahead of print]

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT04515511
• Other Study ID Numbers: PUMCH fc
• First Posted: August 17, 2020
• Last Update Posted: September 3, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: In our department, we has done a serial clinical studies of fluid challenge, we will do retrospective study first.

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

Keywords provided by Peking Union Medical College Hospital:

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

Additional relevant MeSH terms:

Shock, Septic; Shock; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation