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

Phase 4

Not yet recruiting

• Conditions: Shock
• Interventions: Drug: Compound sodium acetate ringer injection; Drug: Albumin

• Registration Number: NCT05463471
• Lead Sponsor: Peking Union Medical College Hospital

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

Detailed Description

CI/SVI increase amplitude and maintenance time

Study Timeline

• Study First Submitted: 2022-06-20
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Study Start: 2022-08-01
• Primary Completion: 2025-12-12
• Study Completion: 2027-12-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium acetate ringer	Compound sodium acetate ringer injection	-
albumin	Albumin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Cardiac output Index(CI) change	2 hour	The changes of cardiac output index before and after volume expansion were compared
Percentage of Stroke Volume Index（SVI）change	2 hour	The changes of Stroke Volume Index before and after volume expansion were compared

Secondary Outcome Measures

Name	Time	Method
Duration of Cardiac output Index(CI) change	2 hour	The duration of cardiac output index changes before and after volume expansion was compared
Duration of Stroke Volume Index（SVI）change	2 hour	The duration of Stroke Volume Index changes before and after volume expansion was compared