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NCT Number: NCT05463471

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

CI/SVI increase amplitude and maintenance time

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compound sodium acetate ringer injection

Drug

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

ALBUMIN

Drug

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

Primary outcomes

  1. Percentage of Cardiac output Index(CI) change

    Time frame: 2 hour

    The changes of cardiac output index before and after volume expansion were compared

  2. Percentage of Stroke Volume Index(SVI)change

    Time frame: 2 hour

    The changes of Stroke Volume Index before and after volume expansion were compared

Secondary outcomes

  1. Duration of Cardiac output Index(CI) change

    Time frame: 2 hour

    The duration of cardiac output index changes before and after volume expansion was compared

  2. Duration of Stroke Volume Index(SVI)change

    Time frame: 2 hour

    The duration of Stroke Volume Index changes before and after volume expansion was compared

Study contacts

Contact information is provided by the study sponsor or research team.

Yun Long, doctor

CONTACT

[email protected]

86-010-69152300

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jul 19, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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