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

NCT04515511 | Unknown

• 1 other identifier: PUMCH fc
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Hemodynamic Instability; Fluid Therapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Oxygen saturation

  Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes

• Carbon dioxide partial pressure

  Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes

• Hemoglobin

  Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes

• Heart rate

  Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes

• Mean arterial pressure

  Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes

Study Arms (1)

standard care

EXPERIMENTAL

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

Interventions

4% gelatin OTHER

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.

Also known as: Pulmonary artery catheter

standard care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Li Weng

Beijing, Beijing Municipality, 100102, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34935687 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Gelatin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Li Weng, Professor

CONTACT

+8618600017819; wengli@gmail.com

Du Bin, Professor

CONTACT

+8615601348897; dubin98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 17, 2020
• Study Start: July 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2022
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)