Clinical trial NCT04621981: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis, Septic Shock
Keywords: Fluid Resuscitation, Crystalloid Solution
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Sequential Organ Failure Assessment(SOFA) value at 24h
timeFrame: 0 hours, 24 hours
Secondary outcomes:
measure: Serum lactate clearance rate
timeFrame: 0 hours, 6 hours
measure: The proportion of patients with serum lactate clearance rate>30%
timeFrame: 0 hours, 6 hours, 24 hours
measure: Changes in pH value over time, and the lowest pH value during hospitalization
timeFrame: 0 hours, 3 hours, 6 hours, 24 hours
measure: Changes in base residue (BE value) over time
timeFrame: 0 hours, 3 hours, 6 hours, 24 hours
measure: Changes in serum bicarbonate(HCO3-) over time
timeFrame: 0 hours, 3 hours, 6 hours, 24 hours
measure: The proportion of patients with hyperchloremia
timeFrame: 0 hours, 3 hours, 24 hours
measure: Changes in SOFA score over time
timeFrame: 0 hours, 24 hours, 48 hours, 72 hours
measure: Changes in APACHEII score over time
timeFrame: 0 hours, 24 hours, 48 hours, 72 hours
measure: Mechanical ventilation time(h)
timeFrame: Within 7 days
measure: The proportion of patients receiving RRT
timeFrame: Within 7 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Lina Zhang
role: PRINCIPAL_INVESTIGATOR
References: