ShockPhase 4NCT05463471
Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients
A Phase 4 study testing Compound sodium acetate ringer injection and Albumin in people with Shock, run by Peking Union Medical College Hospital.
Trial summary
To compare the direct effect of sodium acetate ringer injection or albumin on volume expansion in shock patients, and to provide reference for volume resuscitation strategy in shock patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Compound sodium acetate ringer injection and Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 12 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old, gender unlimited
- Shock requires volume resuscitation:
- Insufficient tissue perfusion: wet and cold skin, decreased urine volume (<0.5ml/kg/h), change of consciousness, blood lactate >2.0mmol/l or vasoactive drugs are required to maintain map>65mmhg
- Presence of volume reactivity: (under controlled ventilation) PPV ≥ 15% or passive leg raising test (+) or (under controlled ventilation) IVC variability ≥ 18% or the presence of volume reactivity as judged by clinicians
- The patient has no obvious restlessness, RASS ≤ 0
- The legal representative of the subject signs the informed consent form-
Who cannot join
- Pregnant and lactating women
- End stage patients
- BMI ≤ 15 or BMI ≥ 50
- Contraindication of indwelling central vein catheter and invasive arterial catheter
- Patients in ECMO and / or IABP therapy
- Hemorrhagic shock, blood products such as concentrated red blood cells, plasma and platelets will be infused within 1 hour
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- Myocardial infarction, NYHA grade IV
- Patients with hyperkalemia, hypercalcemia, hypermagnesemia and hypothyroidism
- Allergic to compound sodium acetate ringer injection or albumin or with known side effects
- Other factors that may affect the monitoring and evaluation of relevant indicators
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients: a Prospective Randomized Controlled Study
To compare the direct effect of sodium acetate ringer injection or albumin on volume expansion in shock patients, and to provide reference for volume resuscitation strategy in shock patients
Read the detailed description
CI/SVI increase amplitude and maintenance time
- Conditions
- Shock
- Being tested
- Compound sodium acetate ringer injection, Albumin
- Keywords
- shock, sodium acetate ringer, albumin
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound sodium acetate ringer injectionDrug
Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes
AlbuminDrug
Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes
| Study group | Role | What they receive |
|---|---|---|
| sodium acetate ringer | Experimental | Not described Receives: Drug: Compound sodium acetate ringer injection |
| albumin | Active comparator | Not described Receives: Drug: Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cardiac output Index(CI) change
The changes of cardiac output index before and after volume expansion were compared
Measured: 2 hour
Percentage of Stroke Volume Index（SVI）change
The changes of Stroke Volume Index before and after volume expansion were compared
Measured: 2 hour
Secondary outcomes (2)
Duration of Cardiac output Index(CI) change
The duration of cardiac output index changes before and after volume expansion was compared
Measured: 2 hour
Duration of Stroke Volume Index（SVI）change
The duration of Stroke Volume Index changes before and after volume expansion was compared
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT05463471
- Sponsor's protocol ID
- PUMCH-ICU-LY
- Status last verified
- Jul 2022
- First submitted
- 20 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05463471
- Acronym / sponsor ID
- PUMCH-ICU-LY
- Conditions
- Shock
- Keywords
- shock, sodium acetate ringer, albumin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 19 Jul 2022 (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.
To compare the direct effect of sodium acetate ringer injection or albumin on volume expansion in shock patients, and to provide reference for volume resuscitation strategy in shock patients
Detailed description
CI/SVI increase amplitude and maintenance time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium acetate ringer | Experimental | Drug: Compound sodium acetate ringer injection |
| albumin | Active comparator | Drug: Albumin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, gender unlimited
- Shock requires volume resuscitation:
- Insufficient tissue perfusion: wet and cold skin, decreased urine volume (<0.5ml/kg/h), change of consciousness, blood lactate >2.0mmol/l or vasoactive drugs are required to maintain map>65mmhg
- Presence of volume reactivity: (under controlled ventilation) PPV ≥ 15% or passive leg raising test (+) or (under controlled ventilation) IVC variability ≥ 18% or the presence of volume reactivity as judged by clinicians
- The patient has no obvious restlessness, RASS ≤ 0
Key exclusion criteria (10 listed)
- Pregnant and lactating women
- End stage patients
- BMI ≤ 15 or BMI ≥ 50
- Contraindication of indwelling central vein catheter and invasive arterial catheter
- Patients in ECMO and / or IABP therapy
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 |
|---|---|---|
| Compound sodium acetate ringer injectionQuickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes | Drug | sodium acetate ringer |
| AlbuminQuickly infuse 500ml of albumin for volume expansion within 20-30 minutes | Drug | albumin |
Primary outcome
Percentage of Cardiac output Index(CI) change
Time frame: 2 hour
The changes of cardiac output index before and after volume expansion were compared
Percentage of Stroke Volume Index（SVI）change
Time frame: 2 hour
The changes of Stroke Volume Index before and after volume expansion were compared
2 secondary outcomes
Duration of Cardiac output Index(CI) change
Time frame: 2 hour
Duration of Stroke Volume Index（SVI）change
Time frame: 2 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound sodium acetate ringer injection and Albumin in people with Shock, run by Peking Union Medical College Hospital.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Long, doctor (86-010-69152300, ly_icu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Cardiac output Index(CI) change (time frame: 2 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2022.