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

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05463471
• Other study ID #: PUMCH-ICU-LY
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: December 12, 2027

Study information

• Verified date: July 2022
• Source: Peking Union Medical College Hospital
• Contact: Yun Long, doctor
• Phone: 86-010-69152300
• Email: ly_icu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

CI/SVI increase amplitude and maintenance time

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 12, 2027
• Est. primary completion date: December 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

Drug:
• Compound sodium acetate ringer injection
Quickly infuse 500ml of compound sodium acetate ringer injection for volume expansion within 20-30 minutes
• Albumin
Quickly infuse 500ml of albumin for volume expansion within 20-30 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Cardiac output Index(CI) change	The changes of cardiac output index before and after volume expansion were compared	2 hour
Primary	Percentage of Stroke Volume Index(SVI)change	The changes of Stroke Volume Index before and after volume expansion were compared	2 hour
Secondary	Duration of Cardiac output Index(CI) change	The duration of cardiac output index changes before and after volume expansion was compared	2 hour
Secondary	Duration of Stroke Volume Index(SVI)change	The duration of Stroke Volume Index changes before and after volume expansion was compared	2 hour