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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05463471

Enrollment

500

Registered

2022-07-19

Start date

2022-08-01

Completion date

2027-12-12

Last updated

2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock

Keywords

shock, sodium acetate ringer, albumin

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

Interventions

DRUGCompound sodium acetate ringer injection

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

DRUGAlbumin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactYun Long, doctor

ly_icu@aliyun.com86-010-69152300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026