Hypovolemia, acute normovolemic hemodilution (ANH)
Conditions
Interventions
Experimental group:Hydroxyethyl starch 130/0.4 electrolyte produced by Huaxia Shengsheng Pharmaceutical Co., Ltd
Control group:Volulyte 6% hydroxyethyl starch 130/0.4 electrolyte injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age is 18~65 years old, gender is not limited (including boundary value); (2) Weight not less than 50 kg for males, not less than 45 kg for females, not more than 100 kg, and body mass index [BMI = weight (kg)/height2(m^2)] within the range of 19.0~30.0 kg/m^2 (including borderline values); (3) Elective surgery is planned and the expected duration of surgery is less than 6 h; (4) Anticipated ANH blood collection of 10% to 15% of the total blood volume; (5) Hb>=110 g/L and Hct >=33%; (6) American Society of Anesthesiologists (ASA) rating ?~?; (7) Voluntary participation and written informed consent.
Exclusion criteria
Exclusion criteria: (1) Known hypersensitivity or allergy to starch and any component of the test drug; (2) Received anemia-related therapy, colloidal solutions, and/or blood products 14 days prior to surgery; (3) Hematologic disorders (e.g., sickle cell anemia, disorders of bead production anemia), excessive blood catecholamine levels (pheochromocytoma); (4) Suffering from severe cerebrovascular disease; (5) Those with pre-existing indications of aortic insufficiency of closure, aortic constriction, or severe peripheral vascular disease, which the investigator determines to be inappropriate for participation in this trial; (6) Hypertensive patients with poorly controlled blood pressure (SBP>=160 mmHg and/or DBP>=100 mmHg) and/or inability to discontinue medication such as angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor antagonists (ARBs) antihypertensive medications, or diuretics 10 hours prior to the procedure; (7) History of poorly controlled diabetes mellitus, which is judged by the investigator to be inappropriate for participation in this trial; (8) History of prior epilepsy and cerebral infarction (except for clinically insignificant lacunar cerebral infarction); (9) History of advanced malignancy (except non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ that has been cured and does not require follow-up); (10) Significant risk of bleeding or coagulation disorders that are assessed by the investigator to be unsuitable for surgery, including but not limited to: a) Previous/existing thrombosis or thromboembolic event, or increased risk of thrombosis or thromboembolic event; b) Requirement for antiplatelet or anticoagulant medications (e.g., warfarin, clopidogrel) other than acetylsalicylic acid (up to 100 mg/d); c) Prior history of gastrointestinal, intracerebral hemorrhage or other bleeding events considered severe, such as those caused by the use of nonsteroidal anti-inflammatory drugs; d) Prolonged PT > 3 seconds above the upper limit of normal or prolonged APTT > 10 seconds above the upper limit of normal and assessed by the investigator to be unsuitable for surgery; e) PLT 2x upper limit of normal values; Albumin level 1.5 times upper limit of normal value; (15) Those with abnormal renal function assessed at Screening and assessed by the Investigator to be unsuitable for surgery: Cr or BUN/Urea > 1.5 times the upper limit of normal values; (16) Presence of water-electrolyte disturbances during the Screening Period; (17) Presence of serious cardiac disease including, but not limited to, unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to Screening), myocardial infarction (within 6 months prior to Screening), New York Heart Association (NYHA) Classification >= III, congestive heart failure, severe arrhythmias poorly controlled by
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in beat-to-beat volume (SV) 5 min after completion of ANH compared with the immediate period before the start of ANH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in inferior vena cava diameter (IVC) 5 min after completion of ANH compared to immediately before the start of ANH.;Changes in cardiac output (CO), stroke volume variation per beat (SVV), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) 5 min after completion of ANH compared with the immediate period before the start of ANH;Changes in Hb and Hct 5 min after completion of ANH compared with the immediate period before the start of ANH;Fluid intake and output 5 min after completion of ANH compared to the immediate period before the start of ANH;Allogeneic blood (erythrocytes, fresh frozen plasma, whole blood) transfusions from immediately before the start of ANH to 2h after the end of the procedure; | — |
Countries
China
Contacts
Public ContactFeng Yi
Peking University People's Hospital
Outcome results
None listed