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

Last updated: July 18, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT05463471
PUMCH-ICU-LY
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 drugsare required to maintain map>65mmhg
  3. Presence of volume reactivity: (under controlled ventilation) PPV ≥ 15% or passive legraising test (+) or (under controlled ventilation) IVC variability ≥ 18% or thepresence 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

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 andplatelets 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 sideeffects
  10. Other factors that may affect the monitoring and evaluation of relevant indicators

Study Design

Total Participants: 500
Study Start date:
August 01, 2022
Estimated Completion Date:
December 12, 2027

Study Description

CI/SVI increase amplitude and maintenance time