Septic ShockNCT04515511
Whether a Minimal Volume Could Predict Fluid Responsiveness Using Thermodilution by PAC in Septic Shock Patients
A study testing 4% gelatin in people with Septic Shock and Hemodynamic Instability, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Hemodynamic Instability, Fluid Therapy
- What is being tested?
- 4% gelatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Li Weng
Beijing, Beijing Municipality, 100102
Li Weng, professor, 15601348897, wengli@gmail.com
Bin Du, professor, +8618600017819, dubin98@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Septic Shock, Hemodynamic Instability, Fluid Therapy
- Being tested
- 4% gelatin
- Keywords
- Sepsis/Septic shock, Hemodynamic monitor, Fluid challenge, Cardiac output, Pulmonary artery catheter, Thermodilution
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% gelatinOther
Also called Pulmonary artery catheter
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 4% gelatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Jul 2019
- Primary completion1 Aug 2020
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515511
- Sponsor's protocol ID
- PUMCH fc
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our department, we has done a serial clinical studies of fluid challenge, we will do retrospective study first.
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.
PubMed 34935687
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Intensive Care Unit of PUMCH
- ClinicalTrials.gov ID
- NCT04515511
- Acronym / sponsor ID
- PUMCH fc
- Conditions
- Septic Shock, Hemodynamic Instability, Fluid Therapy
- Keywords
- Sepsis/Septic shock, Hemodynamic monitor, Fluid challenge, Cardiac output, Pulmonary artery catheter, Thermodilution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standard care | Experimental | Other: 4% gelatinICU 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4% gelatinAlso: Pulmonary artery catheterPulmonary 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 | standard care |
Primary outcome
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).
6 secondary outcomes
Oxygen saturation
Time frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Carbon dioxide partial pressure
Time frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Hemoglobin
Time frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes
Heart rate
Time frame: Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Mean arterial pressure
Time frame: Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Central venous pressure
Time frame: Baseline and immediately after each bolus of 100 mL colloid, average 1 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 34935687Yang 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.
- Individual participant dataSharing planned: No. In our department, we has done a serial clinical studies of fluid challenge, we will do retrospective study first.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4% gelatin in people with Septic Shock and Hemodynamic Instability, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Weng, Professor (+8618600017819, wengli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: Baseline and immediately after each bolus of 100 mL colloid, average 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.