NCT04449757

Brief Summary

In this prospective randomized controlled trial, investigators aim to study the effects and safety of bicarbonated Ringer's solution in patients with septic shock compared with lactated ringer's solution, and provide evidence for current fluid resuscitation strategies for septic shock.

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
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

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

May 27, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

May 27, 2020

Last Update Submit

June 23, 2020

Conditions

Septic ShockFluid ResuscitationCrystalloid SolutionIntensive Care Unit

Keywords

septic shockfluid resuscitationcrystalloid solutionintensive care unit

Outcome Measures

Primary Outcomes (1)

  • the average doses of vasopressors

    total doses of norepinephrine÷weight÷duration of usage

    From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.

Secondary Outcomes (8)

  • the PH value

    0, 3 hours, 6 hours, 12 hours, 24 hours

  • the BE value

    0, 3 hours, 6 hours, 12 hours, 24 hours

  • shock reversal time

    From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.

  • total volume of fluids before hemodynamic stabilization

    From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.

  • the change of serum lactate value at the 6th hour

    6 hours

  • +3 more secondary outcomes

Study Arms (2)

bicarbonated ringer's solution

EXPERIMENTAL

We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock.

Drug: Bicarbonated Ringer's solution

lactated ringer's solution

EXPERIMENTAL

We apply lactated ringer's solution as resuscitation fluid to patients with septic shock.

Drug: Lactated Ringer's solution

Interventions

Bicarbonated Ringer's solutionDRUG

Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.

Also known as: Ringers Bicarbonate
bicarbonated ringer's solution
Lactated Ringer's solutionDRUG

Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.

Also known as: Ringers Lactate
lactated ringer's solution

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. At the age of 18 to 75;
  • \. Being treated in the ICU;
  • \. Diagnosed as septic shock according tho the definition of Sepsis 3.0 with fluid resuscitation requirement.

You may not qualify if:

  • \. Severe hepatic failure;
  • \. Possible brain injury;
  • \. With absolute contraindications for central vena catheterization;
  • \. Ever participated in another clinical trial within 30 days prior enrollment;
  • \. Have corrected metabolic acidosis through alkaline drug application within 24 hours prior to enrollment;
  • \. Hypermagnesemia or hypothyroidism;
  • \. Pregnant of breast-feeding women;
  • \. Considered inevitable death;
  • \. Other situations where investigators think enrollment is not appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

bicarbonated Ringer's solutionRinger's Lactate

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Chief physician

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 29, 2020

Study Start

July 1, 2020

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

June 29, 2020

Record last verified: 2020-06

Locations

CN(1)