Tags

Type your tag names separated by a space and hit enter

The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients.
Anesth Analg. 2008 Oct; 107(4):1110-21.A&A

Abstract

BACKGROUND

Acute hypertension during cardiac surgery can be difficult to manage and may adversely affect patient outcomes. Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure (BP). The Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events trial (ECLIPSE) was performed to compare the safety and efficacy of clevidipine (CLV) with nitroglycerin (NTG), sodium nitroprusside (SNP), and nicardipine (NIC) in the treatment of perioperative acute hypertension in patients undergoing cardiac surgery.

METHODS

We analyzed data from three prospective, randomized, open-label, parallel comparison studies of CLV to NTG or SNP perioperatively, or NIC postoperatively in patients undergoing cardiac surgery at 61 medical centers. Of the 1964 patients enrolled, 1512 met postrandomization inclusion criteria of requiring acute treatment of hypertension based on clinical criteria. The patients were randomized 1:1 for each of the three parallel comparator treatment groups. The primary outcome was the incidence of death, myocardial infarction, stroke or renal dysfunction at 30 days. Adequacy and precision of BP control was evaluated and is reported as a secondary outcome.

RESULTS

There was no difference in the incidence of myocardial infarction, stroke or renal dysfunction for CLV-treated patients compared with the other treatment groups. There was no difference in mortality rates between the CLV, NTG or NIC groups. Mortality was significantly higher, though, for SNP-treated patients compared with CLV-treated patients (P=0.04). CLV was more effective compared with NTG (P=0.0006) or SNP (P=0.003) in maintaining BP within the prespecified BP range. CLV was equivalent to NIC in keeping patients within a prespecified BP range; however, when BP range was narrowed, CLV was associated with fewer BP excursions beyond these BP limits compared with NIC.

CONCLUSIONS

CLV is a safe and effective treatment for acute hypertension in patients undergoing cardiac surgery.

Links

Aggregator Full Text

Authors+Show Affiliations

Aronson S
Department of Anesthesiology, Duke University Medical Center, Duke South, Room 102 Baker House, Durham, NC 27710, USA. arons002@mc.duke.ed
Dyke CM
No affiliation info available
Stierer KA
No affiliation info available
Levy JH
No affiliation info available
Cheung AT
No affiliation info available
Lumb PD
No affiliation info available
Kereiakes DJ
No affiliation info available
Newman MF
No affiliation info available

MeSH

Acute DiseaseAgedAged, 80 and overAntihypertensive AgentsBlood PressureCalcium Channel BlockersCardiac Surgical ProceduresFemaleHumansHypertensionIntraoperative ComplicationsMaleNicardipineNitroglycerinNitroprussidePerioperative CarePostoperative ComplicationsPreoperative CarePyridines

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18806012

Clinical Trial Links

Nicardipine vs Esmolol Craniotomy Emergence
Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection
Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)
Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)
Risk Factors for Complications After Carotid Endarterectomy
Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)
Influence of Elevated Baseline Serum Creatinine and Body Composition on Acute Kidney Injury in Cardiac Surgery

Citation

Aronson, Solomon, et al. "The ECLIPSE Trials: Comparative Studies of Clevidipine to Nitroglycerin, Sodium Nitroprusside, and Nicardipine for Acute Hypertension Treatment in Cardiac Surgery Patients." Anesthesia and Analgesia, vol. 107, no. 4, 2008, pp. 1110-21.
Aronson S, Dyke CM, Stierer KA, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008;107(4):1110-21.
Aronson, S., Dyke, C. M., Stierer, K. A., Levy, J. H., Cheung, A. T., Lumb, P. D., Kereiakes, D. J., & Newman, M. F. (2008). The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesthesia and Analgesia, 107(4), 1110-21. https://doi.org/10.1213/ane.0b013e31818240db
Aronson S, et al. The ECLIPSE Trials: Comparative Studies of Clevidipine to Nitroglycerin, Sodium Nitroprusside, and Nicardipine for Acute Hypertension Treatment in Cardiac Surgery Patients. Anesth Analg. 2008;107(4):1110-21. PubMed PMID: 18806012.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. AU - Aronson,Solomon, AU - Dyke,Cornelius M, AU - Stierer,Kevin A, AU - Levy,Jerrold H, AU - Cheung,Albert T, AU - Lumb,Philip D, AU - Kereiakes,Dean J, AU - Newman,Mark F, PY - 2008/9/23/pubmed PY - 2008/10/10/medline PY - 2008/9/23/entrez SP - 1110 EP - 21 JF - Anesthesia and analgesia JO - Anesth Analg VL - 107 IS - 4 N2 - BACKGROUND: Acute hypertension during cardiac surgery can be difficult to manage and may adversely affect patient outcomes. Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure (BP). The Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events trial (ECLIPSE) was performed to compare the safety and efficacy of clevidipine (CLV) with nitroglycerin (NTG), sodium nitroprusside (SNP), and nicardipine (NIC) in the treatment of perioperative acute hypertension in patients undergoing cardiac surgery. METHODS: We analyzed data from three prospective, randomized, open-label, parallel comparison studies of CLV to NTG or SNP perioperatively, or NIC postoperatively in patients undergoing cardiac surgery at 61 medical centers. Of the 1964 patients enrolled, 1512 met postrandomization inclusion criteria of requiring acute treatment of hypertension based on clinical criteria. The patients were randomized 1:1 for each of the three parallel comparator treatment groups. The primary outcome was the incidence of death, myocardial infarction, stroke or renal dysfunction at 30 days. Adequacy and precision of BP control was evaluated and is reported as a secondary outcome. RESULTS: There was no difference in the incidence of myocardial infarction, stroke or renal dysfunction for CLV-treated patients compared with the other treatment groups. There was no difference in mortality rates between the CLV, NTG or NIC groups. Mortality was significantly higher, though, for SNP-treated patients compared with CLV-treated patients (P=0.04). CLV was more effective compared with NTG (P=0.0006) or SNP (P=0.003) in maintaining BP within the prespecified BP range. CLV was equivalent to NIC in keeping patients within a prespecified BP range; however, when BP range was narrowed, CLV was associated with fewer BP excursions beyond these BP limits compared with NIC. CONCLUSIONS: CLV is a safe and effective treatment for acute hypertension in patients undergoing cardiac surgery. SN - 1526-7598 UR - https://www.unboundmedicine.com/medline/citation/18806012/The_ECLIPSE_trials:_comparative_studies_of_clevidipine_to_nitroglycerin_sodium_nitroprusside_and_nicardipine_for_acute_hypertension_treatment_in_cardiac_surgery_patients_ L2 - https://doi.org/10.1213/ane.0b013e31818240db DB - PRIME DP - Unbound Medicine ER -