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AzTrials

Coronary Artery DiseasePhase 4NCT01463917

Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

A Phase 4 study testing Hypertonic solution and Isotonic in people with Coronary Artery Disease, run by Hospital Pitangueiras at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a comparison between Hypertonic versus isotonic solution in a double blind randomized trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal branch. Hypertonic solution should provide better tolerance for heart mobilization with less volume expansion and less drugs. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease
What is being tested?
Hypertonic solution and Isotonic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteBrazil
Study dates
Sep 2011to Apr 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Off pump CABG targeting the left marginal branch

Who cannot join

  • On pump surgery

Trial locations and contacts

1 site in 1 country.

Roberto R Silva, MD PHD contact

55-11-45215757

rochaesilva@incor.usp.br

Brazil1 site, 1 recruiting

  • Hospital Pitangueiras

    Jundiaí, São Paulo, 1295

    Ricardo De Mola, MD, 55-11-45276226, ricardo_485@terra.com.br

    Ricardo De Mola, MD

    Recruiting

Other trials in Brazil

About this study

Official title: Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch

This is a comparison between Hypertonic versus isotonic solution in a double blind randomized trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal branch.

Hypertonic solution should provide better tolerance for heart mobilization with less volume expansion and less drugs.

Being tested
Hypertonic solution, Isotonic
Keywords
Coronary Artery Bypass, Off-Pump, Saline Solution, Hypertonic
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypertonic solutionDrug

    Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.

  • IsotonicDrug

    Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.

Study groups in NCT01463917
Study groupRoleWhat they receive
HypertonicActive comparatorUse of Hypertonic solution during left marginal branch CABG surgery.
Receives: Drug: Hypertonic solution
IsotonicPlacebo comparatorUse of Isotonic solution during left marginal branch CABG surgery.
Receives: Drug: Isotonic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Use of vasoactive drugs in left marginal branch off pump CABG surgery

    Comparison between hypertonic and isotonic solutions for need of vasoactive drugs with heart mobilization during left marginal branch off pump CABG surgery. Data will be collected respectively at 1, 5 and 10 minutes after beggining the left branch coronary anastomosis. Data will be type of drug need and dosage until the end os the anastomosis.

    Measured: time related to left branch coronary anastomosis for drug need.

Secondary outcomes (1)

  1. Fluid balance

    Comparison of fluid balance in the operative period between hypertonic and isotonic solutions. Data will be collected at the end of surgery and by next mornning.

    Measured: Operative period and first operative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2012 (estimated)
  4. Study completionApr 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01463917
Sponsor's protocol ID
hypertonic off pump CABS
Status last verified
Oct 2011
First submitted
19 Oct 2011
Last updated
2 Nov 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Velasco IT, Pontieri V, Rocha e Silva M Jr, Lopes OU. Hyperosmotic NaCl and severe hemorrhagic shock. Am J Physiol. 1980 Nov;239(5):H664-73. doi: 10.1152/ajpheart.1980.239.5.H664.

    PubMed 6776826

  • Rocha e Silva M, Braga GA, Prist R, Velasco IT, Granca ES. Isochloremic hypertonic solutions for severe hemorrhage. J Trauma. 1993 Aug;35(2):200-5. doi: 10.1097/00005373-199308000-00005.

    PubMed 7689115

  • Wade CE, Kramer GC, Grady JJ, Fabian TC, Younes RN. Efficacy of hypertonic 7.5% saline and 6% dextran-70 in treating trauma: a meta-analysis of controlled clinical studies. Surgery. 1997 Sep;122(3):609-16. doi: 10.1016/s0039-6060(97)90135-5.

    PubMed 9308620

  • Mazzoni MC, Borgstrom P, Intaglietta M, Arfors KE. Capillary narrowing in hemorrhagic shock is rectified by hyperosmotic saline-dextran reinfusion. Circ Shock. 1990 Aug;31(4):407-18.

    PubMed 1697790

  • Ramires JA, Serrano Junior CV, Cesar LA, Velasco IT, Rocha e Silva Junior M, Pileggi F. Acute hemodynamic effects of hypertonic (7.5%) saline infusion in patients with cardiogenic shock due to right ventricular infarction. Circ Shock. 1992 Jul;37(3):220-5.

    PubMed 1423912

  • Auler JO Jr, Pereira MH, Gomide-Amaral RV, Stolf NG, Jatene AD, Rocha e Silva M. Hemodynamic effects of hypertonic sodium chloride during surgical treatment of aortic aneurysms. Surgery. 1987 May;101(5):594-601.

    PubMed 3576451

  • DeFoe GR, Ross CS, Olmstead EM, Surgenor SD, Fillinger MP, Groom RC, Forest RJ, Pieroni JW, Warren CS, Bogosian ME, Krumholz CF, Clark C, Clough RA, Weldner PW, Lahey SJ, Leavitt BJ, Marrin CA, Charlesworth DC, Marshall P, O'Connor GT. Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting. Northern New England Cardiovascular Disease Study Group. Ann Thorac Surg. 2001 Mar;71(3):769-76. doi: 10.1016/s0003-4975(00)02393-6.

    PubMed 11269449

  • Boldt J, Zickmann B, Ballesteros M, Herold C, Dapper F, Hempelmann G. Cardiorespiratory responses to hypertonic saline solution in cardiac operations. Ann Thorac Surg. 1991 Apr;51(4):610-5. doi: 10.1016/0003-4975(91)90320-p.

    PubMed 2012420

  • Boldt J, Zickmann B, Herold C, Ballesteros M, Dapper F, Hempelmann G. Influence of hypertonic volume replacement on the microcirculation in cardiac surgery. Br J Anaesth. 1991 Nov;67(5):595-602. doi: 10.1093/bja/67.5.595.

    PubMed 1721516

  • Oliveira SA, Bueno RM, Souza JM, Senra DF, Rocha-e-Silva M. Effects of hypertonic saline dextran on the postoperative evolution of Jehovah's Witness patients submitted to cardiac surgery with cardiopulmonary bypass. Shock. 1995 Jun;3(6):391-4.

    PubMed 7544684

  • Sirieix D, Hongnat JM, Delayance S, D'Attellis N, Vicaut E, Berrebi A, Paris M, Fabiani JN, Carpentier A, Baron JF. Comparison of the acute hemodynamic effects of hypertonic or colloid infusions immediately after mitral valve repair. Crit Care Med. 1999 Oct;27(10):2159-65. doi: 10.1097/00003246-199910000-00014.

    PubMed 10548199

  • Tollofsrud S, Noddeland H. Hypertonic saline and dextran after coronary artery surgery mobilises fluid excess and improves cardiorespiratory functions. Acta Anaesthesiol Scand. 1998 Feb;42(2):154-61. doi: 10.1111/j.1399-6576.1998.tb05101.x.

    PubMed 9509195

  • Rocha-E-Silva R, Caneo LF, Lourenco Filho DD, Jatene MB, Barbero-Marcial M, Oliveira SA, Rocha-E-Silva M. First use of hypertonic saline dextran in children: a study in safety and effectiveness for atrial septal defect surgery. Shock. 2003 Nov;20(5):427-30. doi: 10.1097/01.SHK.0000094037.09886.d2.

    PubMed 14560106

  • Kvalheim VL, Farstad M, Steien E, Mongstad A, Borge BA, Kvitting PM, Husby P. Infusion of hypertonic saline/starch during cardiopulmonary bypass reduces fluid overload and may impact cardiac function. Acta Anaesthesiol Scand. 2010 Apr;54(4):485-93. doi: 10.1111/j.1399-6576.2009.02156.x. Epub 2009 Oct 29.

    PubMed 19878097

  • Mustafa I, Leverve XM. Metabolic and hemodynamic effects of hypertonic solutions: sodium-lactate versus sodium chloride infusion in postoperative patients. Shock. 2002 Oct;18(4):306-10. doi: 10.1097/00024382-200210000-00003.

    PubMed 12392272

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hypertonic solution and Isotonic in people with Coronary Artery Disease, run by Hospital Pitangueiras at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roberto R Silva, MD PHD (55-11-45215757, rochaesilva@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use of vasoactive drugs in left marginal branch off pump CABG surgery (time frame: time related to left branch coronary anastomosis for drug need.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01463917, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.

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