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Study on the resuscitation effect of 5% albumin Plus Ringer's acetate on septic shock-a single- center, prospective, randomized, open-label, parallel controlled trial

Study on the resuscitation effect of 5% albumin Plus Ringer's acetate on septic shock-a single- center, prospective, randomized, open-label, parallel controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091430
Enrollment
Unknown
Registered
2024-10-28
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

septic shock

Interventions

Experimental group (5% albumin group):Treatment with 5% albumin solution was administered according to the guidelines for fluid resuscitation in septic shock patients within the first 3 hours after fl
Control group (sodium acetate Ringer group):Treatment with sodium acetate Ringer’s solution was administered according to the guidelines for fluid resuscitation in septic shock patients within the fir

Sponsors

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Septic shock was diagnosed in patients who were considered by physicians for volumetric resuscitation. 1. The patients met the diagnostic criteria for "septic shock" (see "* Instructions" below). 2. The age range of the patients was 18-85 years old. 3. There were no gender restrictions for inclusion in the study. 4. Patients voluntarily consented or had agent consent to participate in the study and signed a written informed consent. * Description: The diagnostic criteria for septic shock are consistent with diagnosing sepsis combined with the following conditions: 1. After receiving adequate fluid resuscitation, vasoactive drugs were still required to maintain mean arterial pressure =65 mmHg. 2. Serum lactic acid levels remained >2 mmol/L after adequate fluid resuscitation. Suspected infection and qSOFA score =2 were used as diagnostic criteria for sepsis. qSOFA scoring criteria: 1. Respiratory rate =22 times/min 2. Glasgow coma score <15 3.Systolic blood pressure <100mmHg

Exclusion criteria

Exclusion criteria: 1.Shock caused by other etiologies; 2.History of previous adverse reactions to human blood albumin; 3.Traumatic brain injury; 4.Plasma exchange therapy; 5.Presence of severe organic cardiopulmonary disease (NYHA grade III-IV); 6.Pregnancy status; 7.Participation in another concurrent intervention study; 8.Refusal to participate in the experiment due to religious beliefs; 9.Patients deemed ineligible for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Mean arterial pressure;Types of vasoactive drugs;Vasoactive drug dosage;Daily fluid intake;Daily fluid output;Marshall score;SOFA score;APACHE - II score;Mechanical ventilation duration;ICU length of stay;ICU hospitalization costs;CRRT treatment time;total blood transfusion volume;

Countries

China

Contacts

Public ContactXiaojian Wan

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

xiaojian_wan@yeah.net+86 138 1888 6561

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026