Effect of Hydration Guided by Vigileo on the Prevention of CIN After PCI for Patients With AMI

Myocardial Infarction Clinical Trial

Official title:

Effect of Hydration Guided by Vigileo on the Prevention of Contrast Induced Nephropathy After Emergency PCI for Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382313
• Other study ID #: sf2020-2-5012
• Status: Completed
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: December 21, 2022

Study information

• Verified date: January 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, Vigileo is used to guide hydration adjustment, and SCr is used to estimate renal function. The aim of the study is to investigate the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy in patients with acute myocardial infarction who undergo PCI.

Description:

This study was conducted in patients with acute myocardial infarction who undergo emergency PCI in Chinese PLA General Hospital. The patients were randomly divided into two groups: the adequate hydration group guided by Vigileo and control group. For the adequate hydration group guided by Vigileo, Vigileo equipment is used to perform hemodynamic monitoring through the femoral or radial arteries to obtain relevant hemodynamic parameters (CO, SV, SVV), and the fluid-rehydration velocity of normal saline is adjusted according to the hemodynamic parameters, and the hydration also lasts 24 hours after operation. For the control group, the routine hydration regimen is adopted, perioperative saline ≤500 ml hydration. The changes of renal function (serum creatinine, serum cystatin), symptoms and signs of cardiac insufficiency during perioperative period and cardiac objective indexes are observed. The incidence of postoperative acute pulmonary edema is recorded, and the major cardiovascular events and hemodialysis events are followed up for 6 months. By comparing the perioperative indexes of heart and kidney function between the intervention group and the control group, the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy after PCI was clarified.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: December 21, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clearly diagnosed STEMI or NSTEMI patients:
• Patients aged 18-80 years
• Patients are scheduled to undergo emergency percutaneous coronary interventions
• Estimated glomerular filtration rate eGFR <120ml / min (according to MDRD formula)
• Sign the informed consent to join the group.

Exclusion Criteria:

• Patients with mechanical complications
• Patients with cardiogenic shock
• Patients with aortic dissection
• Patients who have malignant tumors or short-term progressive diseases that researchers believe improper to be included in the group
• Hemodialysis-dependent patients with end-stage renal failure
• Patients who had a history of exposure to radioactive contrast media within 1 week before or 72 hours after direct PCI
• Patients who are allergic to radioactive contrast agents
• Patients diagnosed with right ventricular myocardial infarction with hypotension (defined as systolic blood pressure =90 mmHg) on admission.

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Infarction
• Kidney Diseases
• Myocardial Infarction

Intervention

Procedure:
• the adequate hydration group guided by Vigileo
If the patient is mechanically ventilated, the following scheme is adopted: if SVV=10%, then adjust the rehydration speed to 1 ml/kg/h; if 10%<SVV<15%, then adjust the rehydration speed to 2 ml/kg/h; if SVV=15%, then adjust the rehydration speed to 3 ml/kg/h. The hydration lasts 24 hours after operation, and the rehydration speed is changed according to the SVV. If the patient does not use mechanical ventilation, the following scheme is adopted: 250ml normal saline is administered within 10 minutes after direct PCI, and the rehydration volume changes to 125ml in patients with mild-to-moderate congestive heart failure. If the increment of SV=15%, then adjust the rehydration speed to 3 ml/kg/h; if 10%=the increment of SV<15%, then adjust the rehydration speed to 2 ml/kg/h; if the increment of SV<10%, then adjust the rehydration speed to 1 ml/kg/h. Reassessed every 1 hour until SV is stable,and the hydration also lasts 24 hours after operation.

Locations

Country	Name	City	State
China	Chinese People's Liberation Army General Hospital	Peking	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Lu jiang hospital

Country where clinical trial is conducted

China, 

References & Publications (22)

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Hofer CK, Senn A, Weibel L, Zollinger A. Assessment of stroke volume variation for prediction of fluid responsiveness using the modified FloTrac and PiCCOplus system. Crit Care. 2008;12(3):R82. doi: 10.1186/cc6933. Epub 2008 Jun 20. — View Citation

Maioli M, Toso A, Leoncini M, Micheletti C, Bellandi F. Effects of hydration in contrast-induced acute kidney injury after primary angioplasty: a randomized, controlled trial. Circ Cardiovasc Interv. 2011 Oct 1;4(5):456-62. doi: 10.1161/CIRCINTERVENTIONS.111.961391. Epub 2011 Oct 4. — View Citation

Marenzi G, Ferrari C, Marana I, Assanelli E, De Metrio M, Teruzzi G, Veglia F, Fabbiocchi F, Montorsi P, Bartorelli AL. Prevention of contrast nephropathy by furosemide with matched hydration: the MYTHOS (Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention) trial. JACC Cardiovasc Interv. 2012 Jan;5(1):90-7. doi: 10.1016/j.jcin.2011.08.017. — View Citation

Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043. — View Citation

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Pannu N, Wiebe N, Tonelli M; Alberta Kidney Disease Network. Prophylaxis strategies for contrast-induced nephropathy. JAMA. 2006 Jun 21;295(23):2765-79. doi: 10.1001/jama.295.23.2765. — View Citation

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Sander M, Spies CD, Berger K, Grubitzsch H, Foer A, Kramer M, Carl M, von Heymann C. Prediction of volume response under open-chest conditions during coronary artery bypass surgery. Crit Care. 2007;11(6):R121. doi: 10.1186/cc6181. — View Citation

Satiroglu O, Cicek Y, Bostan M, Cetin M, Bozkurt E. Acute change in left ventricle end-diastolic pressure after primary percutaneous coronary intervention in patients with ST segment elevation myocardial infarction. Am Heart Hosp J. 2010 Winter;8(2):E86-90. — View Citation

Sugasawa Y, Hayashida M, Yamaguchi K, Kajiyama Y, Inada E. Usefulness of stroke volume index obtained with the FloTrac/ Vigileo system for the prediction of acute kidney injury after radical esophagectomy. Ann Surg Oncol. 2013 Nov;20(12):3992-8. doi: 10.1245/s10434-013-3084-5. — View Citation

Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available. — View Citation

Tumkur SM, Vu AT, Li LP, Pierchala L, Prasad PV. Evaluation of intra-renal oxygenation during water diuresis: a time-resolved study using BOLD MRI. Kidney Int. 2006 Jul;70(1):139-43. doi: 10.1038/sj.ki.5000347. Epub 2006 Mar 29. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced nephropathy	Contrast induced nephropathy is defined as serum creatinine values increased by 0.5 mg/dl or 25% relative to baseline absolute values after direct PCI within 48-72 hours.	48-72 hours after PCI
Secondary	The acute renal injury caused by contrast agent	The acute renal injury caused by contrast agent is defined as the serum creatinine value increased by 0.3 mg/dl than the baseline absolute value after direct PCI within 48 hours.	48 hours after PCI
Secondary	Persistent renal insufficiency	Persistent renal insufficiency is defined as at least 25% decrease compared with baseline in creatinine clearance 3 months after direct PCI.	3 months after PCI
Secondary	renal replacement therapy and/or death from acute renal failure	renal replacement therapy and/or death from acute renal failure	6 months after PCI
Secondary	Major adverse cardiac events	all-cause death, non-lethal acute myocardial infarction, revascularization	6 months after PCI