HypotensionNCT01941472
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness
A study testing fluid challenge in people with Hypotension and Shock, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Shock, Fluid Challenge
- What is being tested?
- fluid challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older ICU patients;
- Septic shock;
- Monitored with PICCO or Swan-Ganz catheter;
- The decision of fluid challenge made by the treating physician;
Who cannot join
- Evidence of fluid overload;
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
MICU of Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
About this study
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
- Being tested
- fluid challenge
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid challengeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Responsiveness
Increase in cardiac index ≥ 10% after fluid challenge
Measured: Immediately after fluid challenge, average 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Du, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941472
- Sponsor's protocol ID
- MICU2013-1
- Status last verified
- Mar 2017
- First submitted
- 31 Aug 2013
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29764550Xu 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.
PubMed 27829180