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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 4

Conditions: Shock

Treatments: Drug: Albumin; Drug: Compound sodium acetate ringer injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05463471

PUMCH-ICU-LY

Details and patient eligibility

About

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

Full description

CI/SVI increase amplitude and maintenance time

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old, gender unlimited

2. 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

3. 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

4. The patient has no obvious restlessness, RASS ≤ 0

5. The legal representative of the subject signs the informed consent form-

Exclusion criteria

1. Pregnant and lactating women
2. End stage patients
3. BMI ≤ 15 or BMI ≥ 50
4. Contraindication of indwelling central vein catheter and invasive arterial catheter
5. Patients in ECMO and / or IABP therapy
6. Hemorrhagic shock, blood products such as concentrated red blood cells, plasma and platelets will be infused within 1 hour
7. Myocardial infarction, NYHA grade IV
8. Patients with hyperkalemia, hypercalcemia, hypermagnesemia and hypothyroidism
9. Allergic to compound sodium acetate ringer injection or albumin or with known side effects
10. Other factors that may affect the monitoring and evaluation of relevant indicators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

sodium acetate ringer

Experimental group

Treatment:

Drug: Compound sodium acetate ringer injection

albumin

Active Comparator group

Treatment:

Drug: Albumin