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Not yet recruiting NCT05463471

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

Phase IV Interventional Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compound sodium acetate ringer injection, Albumin.
Who it may be relevant to
Registry conditions: Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Compound sodium acetate ringer injection
    Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes
  • Drug Albumin
    Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes

Primary outcome measures

  • Percentage of Cardiac output Index(CI) change [Time frame: 2 hour]
  • Percentage of Stroke Volume Index（SVI）change [Time frame: 2 hour]
Secondary outcome measures (2)
  • Duration of Cardiac output Index(CI) change [Time frame: 2 hour]
  • Duration of Stroke Volume Index（SVI）change [Time frame: 2 hour]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05463471 · PUMCH-ICU-LY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗