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

NCT ID: NCT04382313

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2022-12-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Infarction Contrast-induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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the adequate hydration group guided by Vigileo

The hydration speed is adjusted according to SVV or SV by Vigileo

Group Type PLACEBO_COMPARATOR

the adequate hydration group guided by Vigileo

Intervention Type PROCEDURE

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.

the control group

The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lu jiang hospital

UNKNOWN

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qian geng

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.

Reference Type BACKGROUND
PMID: 15464318 (View on PubMed)

From AM, Bartholmai BJ, Williams AW, Cha SS, McDonald FS. Mortality associated with nephropathy after radiographic contrast exposure. Mayo Clin Proc. 2008 Oct;83(10):1095-100. doi: 10.4065/83.10.1095.

Reference Type BACKGROUND
PMID: 18828968 (View on PubMed)

Sadeghi HM, Stone GW, Grines CL, Mehran R, Dixon SR, Lansky AJ, Fahy M, Cox DA, Garcia E, Tcheng JE, Griffin JJ, Stuckey TD, Turco M, Carroll JD. Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction. Circulation. 2003 Dec 2;108(22):2769-75. doi: 10.1161/01.CIR.0000103623.63687.21. Epub 2003 Nov 24.

Reference Type BACKGROUND
PMID: 14638545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15519007 (View on PubMed)

Caspi O, Habib M, Cohen Y, Kerner A, Roguin A, Abergel E, Boulos M, Kapeliovich MR, Beyar R, Nikolsky E, Aronson D. Acute Kidney Injury After Primary Angioplasty: Is Contrast-Induced Nephropathy the Culprit? J Am Heart Assoc. 2017 Jun 24;6(6):e005715. doi: 10.1161/JAHA.117.005715.

Reference Type BACKGROUND
PMID: 28647690 (View on PubMed)

Pyxaras SA, Sinagra G, Mangiacapra F, Perkan A, Di Serafino L, Vitrella G, Rakar S, De Vroey F, Santangelo S, Salvi A, Toth G, Bartunek J, De Bruyne B, Wijns W, Barbato E. Contrast-induced nephropathy in patients undergoing primary percutaneous coronary intervention without acute left ventricular ejection fraction impairment. Am J Cardiol. 2013 Mar 1;111(5):684-8. doi: 10.1016/j.amjcard.2012.11.018. Epub 2012 Dec 19.

Reference Type BACKGROUND
PMID: 23261003 (View on PubMed)

Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.

Reference Type BACKGROUND
PMID: 24856027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16788132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20802248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16572109 (View on PubMed)

Epstein FH, Veves A, Prasad PV. Effect of diabetes on renal medullary oxygenation during water diuresis. Diabetes Care. 2002 Mar;25(3):575-8. doi: 10.2337/diacare.25.3.575.

Reference Type BACKGROUND
PMID: 11874950 (View on PubMed)

Briguori C, Condorelli G. Hydration in contrast-induced acute kidney injury. Lancet. 2014 May 24;383(9931):1786-8. doi: 10.1016/S0140-6736(14)60753-4. No abstract available.

Reference Type BACKGROUND
PMID: 24856014 (View on PubMed)

Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end-diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the Assessment of Pexelizumab in Acute Myocardial Infarction study. Am Heart J. 2013 Nov;166(5):913-9. doi: 10.1016/j.ahj.2013.08.006. Epub 2013 Sep 24.

Reference Type BACKGROUND
PMID: 24176448 (View on PubMed)

Remmelink M, Sjauw KD, Henriques JP, Vis MM, van der Schaaf RJ, Koch KT, Tijssen JG, de Winter RJ, Piek JJ, Baan J Jr. Acute left ventricular dynamic effects of primary percutaneous coronary intervention from occlusion to reperfusion. J Am Coll Cardiol. 2009 Apr 28;53(17):1498-502. doi: 10.1016/j.jacc.2008.12.058.

Reference Type BACKGROUND
PMID: 19389559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21928186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22230154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21972403 (View on PubMed)

Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9.

Reference Type BACKGROUND
PMID: 26685074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23797754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18570641 (View on PubMed)

Hofer CK, Muller SM, Furrer L, Klaghofer R, Genoni M, Zollinger A. Stroke volume and pulse pressure variation for prediction of fluid responsiveness in patients undergoing off-pump coronary artery bypass grafting. Chest. 2005 Aug;128(2):848-54. doi: 10.1378/chest.128.2.848.

Reference Type BACKGROUND
PMID: 16100177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18034888 (View on PubMed)

Ling W, Jiang Z, Liu K, Zhang H, Qian Y, Tian J, Zhang Z, Chen Y, Qian G. Effect of Vigileo/FloTrac System-Guided Aggressive Hydration in Acute Myocardial Infarction Patients to Prevent Contrast-Induced Nephropathy After Urgent Percutaneous Coronary Intervention. Am J Cardiol. 2023 May 15;195:77-82. doi: 10.1016/j.amjcard.2023.03.001. Epub 2023 Apr 3.

Reference Type DERIVED
PMID: 37018968 (View on PubMed)

Other Identifiers

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sf2020-2-5012

Identifier Type: -

Identifier Source: org_study_id

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