Table 1 Trial registration information
Data category | Information |
|---|---|
Primary registration and trial identifying number | ClinicalTrials.gov NCT03685214 |
Secondary identifying numbers | None |
Source(s) of monetary or material support | Wu Jieping Medical Foundation (Project identifier: HRJJ20171026) |
Primary sponsor | Zhongnan Hospital of Wuhan University |
Secondary sponsor | Wu Jieping Medical Foundation |
Contact for public queries | Zhiyong Peng, MD. PhD. [pengzy5@hotmail.com] |
Contact for scientific queries | Zhiyong Peng, MD. PhD. [pengzy5@hotmail.com] |
Public title | Comparison of Balanced Crystalloids and Normal Saline in Septic Patients |
Scientific title | Acetate Ringer’s solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial |
Countries of recruitment | China |
Health condition(s) or problem(s) studied | Crystalloid infusion for septic patients |
Intervention(s) | Acetate Ringer’s solution versus saline |
Key inclusion and exclusion criteria | Inclusion criteria: |
1. At the age of 18 to 80 | |
2. Diagnosed as sepsis (a possible or specific proof for infection plus Sequential Organs Failure Assessment (SOFA) scores ≥ 2) | |
Exclusion criteria: | |
1. Patients once having received RRT | |
2. Patients requiring RRT prior to enrolment | |
3. Patients possessed with only one kidney | |
4. Patients with a medical history of renal transplant | |
5. AKI caused by permanent kidney artery embolism or surgery injury to kidney artery | |
6. AKI caused by glomerulonephritis, interstitial nephritis, or vasculitis | |
7. AKI caused by postrenal obstruction | |
8. Hemolytic uremic syndrome (HUS) or thrombotic thrombocytopenic purpura | |
9. Patients having received fluid resuscitation over 1000 ml within 6 h prior to ICU | |
10. Patients with serum chloride more than 120 mmol/L | |
11. Pregnant women | |
12. Patients enrolled into another clinical trial at the same time | |
Study type | Parallel controlled trial |
Date of first enrolment | March 2019 |
Target sample size | 312 |
Recruitment status | Recruiting |
Primary outcome(s) | MAKE28 |
Key secondary outcomes | 1. The occurrence of AKI |
2. Twenty-eight -day mortality | |
3. Electrolyte disturbance, including hypernatremia, hyperchloremia, and hyperkalemia as well as hyponatremia, hypochloremia, and hypokalemia | |
4. Changes of renal functions based on the biomarkers measured from the participants’ plasma and urine samples collected in the first 3 days after enrolment | |
5. Other clinical outcomes: ICU stay, ventilator days, vasopressor days, and RRT days |