Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients

Study Overview
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Brief Summary
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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
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CI/SVI increase amplitude and maintenance time

Official Title
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Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients: a Prospective Randomized Controlled Study

Conditions
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Shock

Intervention / Treatment
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* Drug: Compound sodium acetate ringer injection
* Drug: Albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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- Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium acetate ringer<br> | Drug: Compound sodium acetate ringer injection<br>* Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes<br>|
| Active Comparator: albumin<br> | Drug: Albumin<br>* Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cardiac output Index(CI) change | The changes of cardiac output index before and after volume expansion were compared | 2 hour | 
| Percentage of Stroke Volume Index（SVI）change | The changes of Stroke Volume Index before and after volume expansion were compared | 2 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Cardiac output Index(CI) change | The duration of cardiac output index changes before and after volume expansion was compared | 2 hour | 
| Duration of Stroke Volume Index（SVI）change | The duration of Stroke Volume Index changes before and after volume expansion was compared | 2 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shock, sodium acetate ringer, albumin