Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness

NCT01941472 | Completed Results DMC

• 1 other identifier: MICU2013-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid challenge is often carried out in critical ill patients. Its responsiveness usually requires invasive monitoring. To use non-invasive methods is very tempting. Investigators hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations provide feasible estimation on fluid responsiveness in critical ill patients.

Conditions

Hypotension; Shock; Fluid Challenge; Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

• Fluid Responsiveness

  Increase in cardiac index ≥ 10% after fluid challenge

  Immediately after fluid challenge, average 5 minutes

Study Arms (1)

Septic shock

EXPERIMENTAL

Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.

Other: fluid challenge

Interventions

fluid challenge OTHER

A bag of 500ml of normal saline or 4% gelatin (Gelofusine, B. Braun Medical (Suzhou) Company Limited, Suzhou, China) is infused within 15 minutes using a bag pressurized to 300 mmHg. All other treatments, including maintenance fluids, dose of vasoactive agents and ventilator settings, remain unchanged during the study period.

Septic shock

Eligibility Criteria

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

You may qualify if:

• years and older ICU patients;
• Septic shock;
• Monitored with PICCO or Swan-Ganz catheter;
• The decision of fluid challenge made by the treating physician;

You may not qualify if:

• Evidence of fluid overload;
• Pregnancy

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

MICU of Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (2)

• Liu G, Huang H, Qin H, Du B. [Predictive value of central venous-to-arterial carbon dioxide partial pressure difference for fluid responsiveness in septic shock patients: a prospective clinical study]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 May;30(5):449-455. doi: 10.3760/cma.j.issn.2095-4352.2018.05.011. Chinese.

  PMID: 29764550 DERIVED

• Xu B, Yang X, Wang C, Jiang W, Weng L, Hu X, Peng J, Du B. Changes of central venous oxygen saturation define fluid responsiveness in patients with septic shock: A prospective observational study. J Crit Care. 2017 Apr;38:13-19. doi: 10.1016/j.jcrc.2016.09.030. Epub 2016 Oct 19.

  PMID: 27829180 DERIVED

MeSH Terms

Conditions

Hypotension; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bin Du
• Organization: Peking Union Medical College Hospital

dubin98@gmail.com

8610-69155036

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical ICU

Study Record Dates

• First Submitted: August 31, 2013
• First Posted: September 13, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-03

Locations

CN (1)