Comparison co-load colloid versus crystalloid to prevent hypotension in the patients undergoing hip or proximal femoral fracture surgery: a randomized controlled trial
Phase 4
- Conditions
- Patients with hip or proximal fracture undergoing spinal anesthesia
- Registration Number
- TCTR20210316007
- Lead Sponsor
- Faculty of Medicine, Prince of Songkla University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Hip or proximal femoral fracture surgery
Planned for spinal anesthesia during surgery
ASA classification I-III
Exclusion Criteria
Coagulopathy
Severe aortic stenosis
Left ventricular ejection fraction less than 30 percent
N-terminal pro-brain natriuretic peptide (NT-proBNP) more than 300 pg/mL
Mobitz type 2 second-degree atrioventricular block) or third-degree atrioventricular block
Congestive heart failure or pulmonary edema
End-stage renal disease or needed of renal replacement therapy
Glomerular filtration rate less than 30 mL/min/1.73sqm
Allergy or hypersensitivity to hydroxyethyl starch
Hyponatremia (serum Na less than 130 mEq/L)
During or recent underwent of another trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of intraoperative hypotension 60 mins Mean arterial blood pressure less than 30 percent from baseline
- Secondary Outcome Measures
Name Time Method Vasopressor requirement 60 mins norepinephrine equivalent dose equals to [norepinephrine (mcg/min) + dopamine (mcg/kg/min)/2] + [epinephrine (mcg/min)] + [phenylephrine (mcg/min)/10],Incidence of acute kidney injury 24 hours Serum creatinine rising over or equal 0.3 mg/d