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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2027-12-12

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

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Detailed Description

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CI/SVI increase amplitude and maintenance time

Conditions

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Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sodium acetate ringer

Group Type EXPERIMENTAL

Compound sodium acetate ringer injection

Intervention Type DRUG

Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes

albumin

Group Type ACTIVE_COMPARATOR

Albumin

Intervention Type DRUG

Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes

Interventions

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Compound sodium acetate ringer injection

Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes

Intervention Type DRUG

Albumin

Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No