Lactic AcidosisNCT01901419

Nitroglycerin Infusion During Cardiac Surgery

A study testing Nitroglycerin infusion in people with Lactic Acidosis and Blood Glucose, High, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic inflammatory response, while insufficient and delayed neutralization of heparin by protamine may contribute to more blood loss during rewarming… Read more about this study

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Lactic Acidosis, Blood Glucose, High
What is being tested?: Nitroglycerin infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteTaiwan
Study dates: 8 Jul 2013to 8 Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

elective cardiac surgery

Who cannot join

heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Tri-Service General Hospital
Taipei, 114

Other trials in Taiwan

About this study

Official title: Nitroglycerin Infusion During Rewarming in Cardiac Surgery and Its Effects on Tissue Perfusion and Coagulation

Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment for unstable angina, myocardial infarction, congestive heart failure, and perioperative hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin infusion during rewarming corrects systemic ischemic stress and facilitates heparin neutralization in cardiac surgery.

Read the detailed description

A randomized clinical trial in a tertiary academic center in patients with cardiac surgery, to receive either nitroglycerin infusion dose of 0-0.1 mcg/kg/min, or 1-5 mcg/kg/min during rewarming in cardiopulmonary bypass.

Conditions: Lactic Acidosis, Blood Glucose, High
Being tested: Nitroglycerin infusion
Keywords: nitroglycerin, cardiopulmonary bypass, cardiac surgery
Medical subject headings: Acidosis, Lactic

What participants receive

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

Nitroglycerin infusionDrug
Also called Millisrol
Nitroglycerin infusion during rewarming

Study groups in NCT01901419
Study group	Role	What they receive
High-dose NTG	Experimental	Nitroglycerin infusion 1-5 mcg/kg/min Receives: Drug: Nitroglycerin infusion
Low-dose NTG	Active comparator	Nitroglycerin infusion 0-0.1 mcg/kg/min Receives: Drug: Nitroglycerin infusion

What is being measured

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

Plasma Lactate Level, Before Incision
Plasma Lactate Level, mmol/L, Before Incision
Measured: Before Incision
Plasma Lactate Level, Before Start of CPB
Plasma Lactate Level, mmol/L, Before Start of CPB
Measured: Before Start of CPB
Plasma Lactate Level, Release of Aortic Clamp
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Measured: Release of Aortic Clamp
Plasma Lactate Level, After Protamine Administration
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Measured: After Protamine Administration
Plasma Lactate Level, Upon Arrival at ICU
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Measured: Upon Arrival at ICU
Plasma Glucose Level, Before Incision
Plasma Glucose Level, mg/dL, Before Incision
Measured: Before Incision
Plasma Glucose Level, Before Start of CPB
Plasma Glucose Level, mg/dL, Before Start of CPB
Measured: Before Start of CPB
Plasma Glucose Level, Release of Aortic Clamp
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Measured: Release of Aortic Clamp
Plasma Glucose Level, After Protamine Administration
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Measured: After Protamine Administration
Plasma Glucose Level, Upon Arrival at ICU
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Measured: Upon Arrival at ICU
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass
Measured: After Initiation of NTG infusion During Rewarming

Secondary outcomes (5)

Activated Coagulation Time, Before Start of CPB
Activated Coagulation Time, sec, Before Start of CPB
Measured: Before Start of CPB
Activated Coagulation Time, After Protamine Administration
Activated Coagulation Time, sec, After Cessation of CPB and Protamine Administration
Measured: After Protamine Administration
Post-op Dopamine Infusion
Infusion Rate of Dopamine, mcg/kg/min, Upon Arrival at ICU
Measured: Upon Arrival at ICU
Time to Extubation
Time from Arrival at ICU to Extubation, hour
Measured: Arrival at ICU and Extubation
Length of ICU Stay
Time from Arrival at ICU to Leaving ICU, day
Measured: Arrival at ICU and Leaving ICU

Timeline

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

8 Jul 20138 Jun 2017

First posted17 Jul 2013 (estimated)
Study start8 Jul 2013
Primary completion8 Jun 2017
Study completion8 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lactic AcidosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized controlled trial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01901419
Sponsor's protocol ID: TSGHIRB 1-102-05-049
Status last verified: Oct 2020
First submitted: 10 Jul 2013
Last updated: 24 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: all IPD that underlie results in a publication are to be shared starting 6 months after journal publication.

Publications

Piquette D, Deschamps A, Belisle S, Pellerin M, Levesque S, Tardif JC, Denault AY. Effect of intravenous nitroglycerin on cerebral saturation in high-risk cardiac surgery. Can J Anaesth. 2007 Sep;54(9):718-27. doi: 10.1007/BF03026868.
PubMed 17766739
Masoumi G, Pour EH, Sadeghpour A, Ziayeefard M, Alavi M, Anbardan SJ, Shirani S. Effect of different dosages of nitroglycerin infusion on arterial blood gas tensions in patients undergoing on- pump coronary artery bypass graft surgery. J Res Med Sci. 2012 Feb;17(2):123-7.
PubMed 23264783

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
Not yet recruitingPhase 1/2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
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All Lactic Acidosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nitroglycerin Infusion During Rewarming in Cardiac Surgery and Its Effects on Tissue Perfusion and Coagulation
ClinicalTrials.gov ID: NCT01901419
Acronym / sponsor ID: TSGHIRB 1-102-05-049
Conditions: Lactic Acidosis, Blood Glucose, High
Keywords: nitroglycerin, cardiopulmonary bypass, cardiac surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Tri-Service General Hospital (TSGH)University, hospital or other
Study start: 8 Jul 2013 (actual)
Primary completion: 8 Jun 2017 (actual)
Study completion: 8 Jun 2017 (actual)
First posted: 17 Jul 2013 (estimated)
Results: Posted 24 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: randomized controlled trial

Arm	Type	Receives
High-dose NTG	Experimental	Drug: Nitroglycerin infusionNitroglycerin infusion 1-5 mcg/kg/min
Low-dose NTG	Active comparator	Drug: Nitroglycerin infusionNitroglycerin infusion 0-0.1 mcg/kg/min

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

elective cardiac surgery

Key exclusion criteria (1 listed)

heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nitroglycerin infusionAlso: MillisrolNitroglycerin infusion during rewarming	Drug	High-dose NTG, Low-dose NTG

Primary outcome

Plasma Lactate Level, Before Incision
Time frame: Before Incision
Plasma Lactate Level, mmol/L, Before Incision
Plasma Lactate Level, Before Start of CPB
Time frame: Before Start of CPB
Plasma Lactate Level, mmol/L, Before Start of CPB
Plasma Lactate Level, Release of Aortic Clamp
Time frame: Release of Aortic Clamp
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Plasma Lactate Level, After Protamine Administration
Time frame: After Protamine Administration
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Plasma Lactate Level, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Plasma Glucose Level, Before Incision
Time frame: Before Incision
Plasma Glucose Level, mg/dL, Before Incision
Plasma Glucose Level, Before Start of CPB
Time frame: Before Start of CPB
Plasma Glucose Level, mg/dL, Before Start of CPB
Plasma Glucose Level, Release of Aortic Clamp
Time frame: Release of Aortic Clamp
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Plasma Glucose Level, After Protamine Administration
Time frame: After Protamine Administration
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Plasma Glucose Level, Upon Arrival at ICU
Time frame: Upon Arrival at ICU
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion
Time frame: After Initiation of NTG infusion During Rewarming
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass

5 secondary outcomes

Activated Coagulation Time, Before Start of CPB
Time frame: Before Start of CPB
Activated Coagulation Time, After Protamine Administration
Time frame: After Protamine Administration
Post-op Dopamine Infusion
Time frame: Upon Arrival at ICU
Time to Extubation
Time frame: Arrival at ICU and Extubation
Length of ICU Stay
Time frame: Arrival at ICU and Leaving ICU

Results and safety

Results posted to the registry on 24 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-dose NTG	40	32
Low-dose NTG	40	31

Primary outcome: Plasma Lactate Level, Before Incision

Time frame: Before Incision. Mean (Standard Deviation). Unit: mmol/L

Measure	High-dose NTG n = 32	Low-dose NTG n = 31
Value	1.1 (0.5)	1.0 (0.4)

High-dose NTG vs Low-dose NTG: p = 0.618, t-test, 2 sided

Primary outcome: Plasma Lactate Level, Before Start of CPB

Time frame: Before Start of CPB. Mean (Standard Deviation). Unit: mmol/L

Measure	High-dose NTG n = 32	Low-dose NTG n = 31
Value	1.4 (0.7)	1.6 (0.7)

High-dose NTG vs Low-dose NTG: p = 0.410, t-test, 2 sided

Primary outcome: Plasma Lactate Level, Release of Aortic Clamp

Time frame: Release of Aortic Clamp. Mean (Standard Deviation). Unit: mmol/L

Measure	High-dose NTG n = 32	Low-dose NTG n = 31
Value	3.1 (1.2)	2.6 (1.0)

High-dose NTG vs Low-dose NTG: p = 0.088, t-test, 2 sided

Primary outcome: Plasma Lactate Level, After Protamine Administration

Time frame: After Protamine Administration. Mean (Standard Deviation). Unit: mmol/L

Measure	High-dose NTG n = 32	Low-dose NTG n = 31
Value	3.3 (1.2)	3.0 (1.1)

High-dose NTG vs Low-dose NTG: p = 0.320, t-test, 2 sided

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30-day mortality and complications.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-dose NTG	2 of 32 (6.3%)	0 of 32 (0%)	1 of 32
Low-dose NTG	2 of 31 (6.5%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): One patient in NTG group experienced re-sternotomy to check bleeding in the same day and another one expired at the 25th day postoperatively due to mediastinitis with septic shock.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17766739Piquette D, Deschamps A, Belisle S, Pellerin M, Levesque S, Tardif JC, Denault AY. Effect of intravenous nitroglycerin on cerebral saturation in high-risk cardiac surgery. Can J Anaesth. 2007 Sep;54(9):718-27. doi: 10.1007/BF03026868.
Background: PubMed 23264783Masoumi G, Pour EH, Sadeghpour A, Ziayeefard M, Alavi M, Anbardan SJ, Shirani S. Effect of different dosages of nitroglycerin infusion on arterial blood gas tensions in patients undergoing on- pump coronary artery bypass graft surgery. J Res Med Sci. 2012 Feb;17(2):123-7.
Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication are to be shared starting 6 months after journal publication.

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An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tso-Chou Lin, MD principal investigator

Tri-Service General Hospital (TSGH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nitroglycerin infusion in people with Lactic Acidosis and Blood Glucose, High, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

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: finished, as of the sponsor's last update on 24 Nov 2020. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Lactate Level, Before Incision (time frame: Before Incision). The study lists 11 primary outcomes in all. 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 NCT01901419, which also lists 2 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 24 Nov 2020.