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

NCT05463471 | Not Yet Recruiting Phase 4

• 1 other identifier: PUMCH-ICU-LY
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Shock

Keywords

shock; sodium acetate ringer; albumin

Outcome Measures

Primary Outcomes (2)

• Percentage of Cardiac output Index(CI) change

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

  2 hour

• Percentage of Stroke Volume Index（SVI）change

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

  2 hour

Secondary Outcomes (2)

• Duration of Cardiac output Index(CI) change

  2 hour

• Duration of Stroke Volume Index（SVI）change

  2 hour

Study Arms (2)

sodium acetate ringer

EXPERIMENTAL

Drug: Compound sodium acetate ringer injection

albumin

ACTIVE COMPARATOR

Drug: Albumin

Interventions

Compound sodium acetate ringer injection DRUG

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

sodium acetate ringer

Albumin DRUG

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

albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Shock

Interventions

Albumins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yun Long, doctor

CONTACT

86-010-69152300; ly_icu@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 19, 2022
• Study Start: August 1, 2022
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 12, 2027
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share