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Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis

Primary Purpose

Sepsis, Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium Bicarbonate Ringer's Solution
Normal Saline
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis, Septic Shock focused on measuring Fluid Resuscitation, Crystalloid Solution

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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;
  • Patients have other conditions that are not appropriate for inclusion according to the researcher's judgment.

Sites / Locations

  • Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sodium Bicarbonate Ringer's Solution

Normal Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Sequential Organ Failure Assessment(SOFA) value at 24h
ΔSOFA=SOFA24h-SOFA0h

Secondary Outcome Measures

Serum lactate clearance rate
(Serum lactete0h-serum lactate6h)/serum lactate0h
The proportion of patients with serum lactate clearance rate>30%
the proportion of patients whose serum lactate decrease by more than 30%
Changes in pH value over time, and the lowest pH value during hospitalization
ΔpH=pH3h/6h/24h-pH0h, and the lowest pH value during hospitalization
Changes in base residue (BE value) over time
ΔBE=BE3h/6h/24h-BE0h
Changes in serum bicarbonate(HCO3-) over time
ΔHCO3-=HCO3-3h/6h/24h-HCO3-0h
The proportion of patients with hyperchloremia
The proportion of patients with hyperchloremia at 3h and 24h.
Changes in SOFA score over time
ΔSOFA=SOFA24h/48h/72h-SOFA0h
Changes in APACHEII score over time
ΔAPACHEII=APACHEII24h/48h/72h-APACHEII0h
Mechanical ventilation time(h)
the length of mechanical ventilation time within 7 days
The proportion of patients receiving RRT
The proportion of patients receiving RRT within 7 days

Full Information

First Posted
November 1, 2020
Last Updated
March 31, 2022
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04621981
Brief Title
Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis
Official Title
Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Sepsis and septic shock are clinical emergencies requiring immediate treatment and fluid resuscitation. Early effective fluid resuscitation can improve the prognosis of patients. So far, there is no perfect crystalloid solution. Normal saline is the most readily available and economical crystalline fluid for clinical resuscitation. It is isoosmotic and can meet the basic needs of patients in the early rehydration. But it lacks acid-base buffer system and potassium, calcium and magnesium ions, and the level of chloride ions is also significantly higher than that of plasma. Sodium Bicarbonate Ringer's solution contains physiological levels of Na+(130mmol/L), K+(4mmol/L), Ca2+(1.5mmol/L), Mg2+(1mmol/L), HCO3-(28mmol/L) and Cl-(109mmol/L). It also has citric acid/ sodium citrate buffer system (Citrate3-1.3mmol/L), pH7.3, and osmotic pressure 276mOsm/L. It is the most similar solution to extracellular fluid. Theoretically,Compared with normal saline, Sodium Bicarbonate Ringer's solution can maintain acid-base balance faster and better when restoring the microcirculation without affecting the level of chloride ion. Therefore we hypothesize that Sodium Bicarbonate Ringer's solution can promote the body to restore to acid-base balance more quickly, and improve organ function more significantly than normal saline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
Fluid Resuscitation, Crystalloid Solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium Bicarbonate Ringer's Solution
Arm Type
Experimental
Arm Description
Intravenous drip, 500~1000ml per time. Infusion speed: 15ml/kg/h or according to guidelines or department routine.
Arm Title
Normal Saline
Arm Type
Active Comparator
Arm Description
Intravenous drip, 500~1000ml per time. Dosage depends on age、weight and symptoms. Infusion speed: According to the department process or clinician's decision.
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate Ringer's Solution
Other Intervention Name(s)
Bicarbonated Ringer's solution
Intervention Description
This group was treated with Sodium Bicarbonate Ringer's Solution.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
physiological saline
Intervention Description
This group was treated with normal saline.
Primary Outcome Measure Information:
Title
Change in Sequential Organ Failure Assessment(SOFA) value at 24h
Description
ΔSOFA=SOFA24h-SOFA0h
Time Frame
0 hours, 24 hours
Secondary Outcome Measure Information:
Title
Serum lactate clearance rate
Description
(Serum lactete0h-serum lactate6h)/serum lactate0h
Time Frame
0 hours, 6 hours
Title
The proportion of patients with serum lactate clearance rate>30%
Description
the proportion of patients whose serum lactate decrease by more than 30%
Time Frame
0 hours, 6 hours, 24 hours
Title
Changes in pH value over time, and the lowest pH value during hospitalization
Description
ΔpH=pH3h/6h/24h-pH0h, and the lowest pH value during hospitalization
Time Frame
0 hours, 3 hours, 6 hours, 24 hours
Title
Changes in base residue (BE value) over time
Description
ΔBE=BE3h/6h/24h-BE0h
Time Frame
0 hours, 3 hours, 6 hours, 24 hours
Title
Changes in serum bicarbonate(HCO3-) over time
Description
ΔHCO3-=HCO3-3h/6h/24h-HCO3-0h
Time Frame
0 hours, 3 hours, 6 hours, 24 hours
Title
The proportion of patients with hyperchloremia
Description
The proportion of patients with hyperchloremia at 3h and 24h.
Time Frame
0 hours, 3 hours, 24 hours
Title
Changes in SOFA score over time
Description
ΔSOFA=SOFA24h/48h/72h-SOFA0h
Time Frame
0 hours, 24 hours, 48 hours, 72 hours
Title
Changes in APACHEII score over time
Description
ΔAPACHEII=APACHEII24h/48h/72h-APACHEII0h
Time Frame
0 hours, 24 hours, 48 hours, 72 hours
Title
Mechanical ventilation time(h)
Description
the length of mechanical ventilation time within 7 days
Time Frame
Within 7 days
Title
The proportion of patients receiving RRT
Description
The proportion of patients receiving RRT within 7 days
Time Frame
Within 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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; Patients have other conditions that are not appropriate for inclusion according to the researcher's judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Zhang
Phone
+8615874875763
Email
zln7095@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lina Zhang
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Zhang

12. IPD Sharing Statement

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Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis

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