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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05463471
• Collaborator: (none)
• Enrollment: 500
• Arms: 2
• Anticipated Duration (Months): 64.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Shock	Drug: Compound sodium acetate ringer injection; Drug: Albumin	Phase 4

Detailed Description

CI/SVI increase amplitude and maintenance time

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients: a Prospective Randomized Controlled Study
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 12, 2025
• Anticipated Study Completion Date: Dec 12, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Cardiac output Index(CI) change [2 hour]

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

2. 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

1. Duration of Cardiac output Index(CI) change [2 hour]

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

2. Duration of Stroke Volume Index（SVI）change [2 hour]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

2. The patient has no obvious restlessness, RASS ≤ 0

3. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT05463471
• Other Study ID Numbers: PUMCH-ICU-LY
• First Posted: Jul 19, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking Union Medical College Hospital: shock; sodium acetate ringer; albumin
• Additional relevant MeSH terms: Shock

Study Results

No Results Posted as of Jul 19, 2022