NCT04621981

Brief Summary

At present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. It is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for patients with sepsis. Therefore, this study focuses on the efficacy and safety of sodium bicarbonate Ringer's solution compared with normal saline.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 11, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

November 1, 2020

Last Update Submit

March 31, 2022

Conditions

Sepsis, Septic Shock

Keywords

Fluid Resuscitation, Crystalloid Solution

Outcome Measures

Primary Outcomes (1)

  • Change in Sequential Organ Failure Assessment(SOFA) value at 24h

    ΔSOFA=SOFA24h-SOFA0h

    0 hours, 24 hours

Secondary Outcomes (10)

  • Serum lactate clearance rate

    0 hours, 6 hours

  • The proportion of patients with serum lactate clearance rate>30%

    0 hours, 6 hours, 24 hours

  • Changes in pH value over time, and the lowest pH value during hospitalization

    0 hours, 3 hours, 6 hours, 24 hours

  • Changes in base residue (BE value) over time

    0 hours, 3 hours, 6 hours, 24 hours

  • Changes in serum bicarbonate(HCO3-) over time

    0 hours, 3 hours, 6 hours, 24 hours

  • +5 more secondary outcomes

Study Arms (2)

Sodium Bicarbonate Ringer's Solution

EXPERIMENTAL

Intravenous drip, 500\~1000ml per time. Infusion speed: 15ml/kg/h or according to guidelines or department routine.

Drug: Sodium Bicarbonate Ringer's Solution

Normal Saline

ACTIVE COMPARATOR

Intravenous drip, 500\~1000ml per time. Dosage depends on age、weight and symptoms. Infusion speed: According to the department process or clinician's decision.

Drug: Normal Saline

Interventions

Sodium Bicarbonate Ringer's SolutionDRUG

This group was treated with Sodium Bicarbonate Ringer's Solution.

Also known as: Bicarbonated Ringer's solution
Sodium Bicarbonate Ringer's Solution
Normal SalineDRUG

This group was treated with normal saline.

Also known as: physiological saline
Normal Saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as sepsis or septic shock according to the definition of Sepsis-3.0 with fluid resuscitation requirement;
  • aged between 18 and 80, male or female;
  • Signed informed Consent (with delay within 24 hours).

You may not qualify if:

  • Patients with hypermagnesemia;
  • Patients with hypothyroidism;
  • Patients predicted to die or discharged within 24 hours after admission;
  • Patients with previous history of mental illness, severe hepatic and renal insufficiency, severe cardiac disease, primary severe central nervous system lesions;
  • Pregnant or breast-feeding women;
  • Patients who have received cardiopulmonary resuscitation；
  • Patients who participated in other clinical trials within 30 days;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

bicarbonated Ringer's solutionSaline Solution

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Lina Zhang

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Zhang

CONTACT

+8615874875763zln7095@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2020

First Posted

November 9, 2020

Study Start

March 11, 2021

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

CN(1)