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
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
Show all 10Show fewer
- 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