Hypovolemia
Conditions
Interventions
Test group:The equal volume of succinylated gelatin electrolyte and sodium acetate injection was intravenously infused in the experimental group
Control group:The equal volume of control succinylated gelatin electrolyte sodium acetate injection was infused intravenously
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-65 years old (including boundary value), regardless of gender. 2. Body weight not less than 50kg, body weight not more than 100kg, body mass index [BMI= weight (kg)/ height ^2(m^2)] in the range of 19.0-30.0 kg/m^2 (including the cut-off value). 3. scheduled elective surgery with expected operation time less than 6 hours. 4. The amount of blood collected by ANH was predicted to be 10%-15% of the total blood volume. 5. subjects' Hb >=110 g/L before enrollment. 6. American Society of Anesthesiologists (ASA) grade I-III. 7. voluntarily participate in the trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of severe cerebrovascular disease or severe psychiatric illness who were deemed by the investigator to be ineligible for the trial. 2. patients with a history of valvular heart disease, coarctation of the aorta, or severe peripheral vascular disease (such as arterial stiffness) who were judged by the investigator to be ineligible for the trial; 3. have serious heart disease, Including, but not limited to, unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), New York Heart Association (NYHA) class =III, congestive heart failure, severe arrhythmias that are poorly controlled with medications, need for mechanical maintenance (e.g., a pacemaker), placement of a cardiac stent, or abnormal findings on echocardiography and/or 12-lead electrocardiogram at screening are clinically relevant. 4. hypertensive patients with poorly controlled blood pressure (SBP >=160mmHg and/or DBP >=100 MMHG), who could not discontinue long-acting antihypertensive drugs such as angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist and potassium sparing diuretics 10 hours before surgery and who were judged by the investigator to be unsuitable for the trial; 5. patients with a history of cirrhosis or abnormal liver function at screening who were not suitable for surgery according to the investigator's assessment :AST or ALT>2 times the upper limit of normal (ULN); Albumin level 1.5 times upper limit of normal (ULN). 6. abnormal renal function assessment at screening and not suitable for surgery according to investigator assessment :Cr or BUN>1.5 times upper limit of normal (ULN). 7. having any of the following respiratory management risks at the time of screening :1) history of asthma (e.g., allergic asthma), wheezing; 2) sleep apnea syndrome; 8. hematological diseases (such as sickle cell anemia, thalassemia, pheochromocytoma), etc. 9. significant bleeding risk or coagulation disorder, with investigator assessment that the patient is not a candidate for surgery, including but not limited to :a) previous/current thrombosis or thromboembolic events, or an increased risk of thrombosis or thromboembolic events; b) prescribing antiplatelet or anticoagulant drugs (e.g. warfarin, clopidogrel) other than aspirin (maximum 100 mg/ day); c) a previous history of gastrointestinal bleeding, intracerebral bleeding, or other bleeding events considered severe, such as those due to the use of nsaids; d) PT prolongation > 3 seconds or APTT prolongation > 10 seconds and considered by the investigator to be unsuitable for surgery; e) PLT=7%) who were deemed by the investigator to be ineligible for the trial. 11. history of malignant tumors (excluding non-metastatic basal cell carcinoma or squamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situ that have been cured for >=5 years and do not require follow-up). 12. hypervolemia (e.g., polycythemia vera), excessive fluid load (e.g., generalized edema). 13. had poorly controlled active infection that was deemed by the investigator to make the subject ineligible for participation in this clinical study. 14. combined with pulmonary edema, dehydration, burns, intestinal obstruction, critical diseases such as sepsis, multiple organ failure, respiratory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stroke Volume (SV);Hematocrit (Hct); | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac output (CO);Stroke volume variation (SVV);The diameter of inferior vena cava (IVC);Systolic blood pressure (SBP);Diastolic Blood pressure (DBP);Hemoglobin (Hb); | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed