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

Sepsis, Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04621981
• Other study ID #: RIN005-R
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2022
• Source: Xiangya Hospital of Central South University
• Contact: Lina Zhang
• Phone: +8615874875763
• Email: zln7095[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Septic Shock
• Toxemia

Intervention

Drug:
• Sodium Bicarbonate Ringer's Solution
This group was treated with Sodium Bicarbonate Ringer's Solution.
• Normal Saline
This group was treated with normal saline.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sequential Organ Failure Assessment(SOFA) value at 24h	?SOFA=SOFA24h-SOFA0h	0 hours, 24 hours
Secondary	Serum lactate clearance rate	(Serum lactete0h-serum lactate6h)/serum lactate0h	0 hours, 6 hours
Secondary	The proportion of patients with serum lactate clearance rate>30%	the proportion of patients whose serum lactate decrease by more than 30%	0 hours, 6 hours, 24 hours
Secondary	Changes in pH value over time, and the lowest pH value during hospitalization	?pH=pH3h/6h/24h-pH0h, and the lowest pH value during hospitalization	0 hours, 3 hours, 6 hours, 24 hours
Secondary	Changes in base residue (BE value) over time	?BE=BE3h/6h/24h-BE0h	0 hours, 3 hours, 6 hours, 24 hours
Secondary	Changes in serum bicarbonate(HCO3-) over time	?HCO3-=HCO3-3h/6h/24h-HCO3-0h	0 hours, 3 hours, 6 hours, 24 hours
Secondary	The proportion of patients with hyperchloremia	The proportion of patients with hyperchloremia at 3h and 24h.	0 hours, 3 hours, 24 hours
Secondary	Changes in SOFA score over time	?SOFA=SOFA24h/48h/72h-SOFA0h	0 hours, 24 hours, 48 hours, 72 hours
Secondary	Changes in APACHEII score over time	?APACHEII=APACHEII24h/48h/72h-APACHEII0h	0 hours, 24 hours, 48 hours, 72 hours
Secondary	Mechanical ventilation time(h)	the length of mechanical ventilation time within 7 days	Within 7 days
Secondary	The proportion of patients receiving RRT	The proportion of patients receiving RRT within 7 days	Within 7 days