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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Shock
• Intervention / Treatment: Drug: Compound sodium acetate ringer injection; Drug: Albumin

Detailed Description

CI/SVI increase amplitude and maintenance time

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yun Long, doctor; Phone Number: 86-010-69152300; Email: ly_icu@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sodium acetate ringer	Drug: Compound sodium acetate ringer injection; Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes
Active Comparator: albumin	Drug: Albumin; Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 12, 2025
• Study Completion (Anticipated): December 12, 2027

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: shock; sodium acetate ringer; albumin
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: PUMCH-ICU-LY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No