HypotensionPhase 2NCT00135668

Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room

A Phase 2 study testing Nitroprusside in people with Hypotension, run by The Emmes Company, LLC at 1 site in United States.

Completed

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

Official record

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Trial summary

Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to… Read more about this study

Who is it for?: Ages Up to 17 years
Conditions the study is for: Hypotension
What is being tested?: Nitroprusside
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 1 siteUnited States
Study dates: Aug 2005to Feb 2009
Phase: Phase 2
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 Up to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Study subjects must meet all of the following criteria:
Subject is less than 17 years of age
Neonates must be full-term gestation and have a body weight of at least 2.5 kg
Subject requires pharmacologically-induced hypotension for acute blood pressure management for surgery or other invasive procedure, e.g., cerebral artery embolization
Duration of the subject's controlled hypotension is expected to be ≥ 2 hours
Subject requires general anesthesia with endotracheal intubation
Subject requires placement of intra-arterial line during the surgical or medical procedure
The subject's parent or legal guardian gives permission (informed consent) and subject gives assent when appropriate.

Who cannot join

Subjects will be excluded if any of the following criteria exist:
Subject has a known allergy to SNP
Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes
Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or procedures
Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
Subject is moribund (death likely to occur within 48 hours)
Subject has a positive result for the urine or serum human chorionic gonadotropin (HCG) test administered at screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305-5401

Other trials in United States

About this study

Official title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel Group, Dose-ranging, Effect-controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside in Pediatric Subjects

Read the detailed description

The trial is a multicenter randomized, double-blind, parallel group, dose-ranging, effect-controlled study examining the effects of sodium nitroprusside in pediatric subjects requiring relative hypotension during a surgical or medical procedure. The goal is to establish the starting and maximum infusion rates that afford optimum blood pressure control in children and a safe dosing regimen in children. The objective is to describe the relationship between the infusion rate of nitroprusside and changes in blood pressure.

The specific aims of this trial are:

To define the onset and offset of blood pressure lowering effects of nitroprusside to obtain adequate instructions for dose titration in the pediatric population.
To construct a dose-response model that defines the relationship between nitroprusside infusion rate and changes in blood pressure in pediatric subjects.
To assess the safety of nitroprusside administration in pediatric subjects requiring controlled reduction of blood pressure.

Conditions: Hypotension
Being tested: Nitroprusside
Keywords: children, sodium nitroprusside, controlled hypotension, dose-response, pharmacokinetics, pharmacodynamics, safety, efficacy
Medical subject headings: Hypotension

What participants receive

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

NitroprussideDrug
Also called Sodium Nitroprusside IV infusion 0.3 mcg/kg/ min
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS (Interactive Voice Response System).
NitroprussideDrug
Also called Sodium Nitroprusside IV infusion 1 mcg/kg/ min
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.
NitroprussideDrug
Also called Sodium Nitroprusside IV infusion 2 mcg/kg/ min
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.
NitroprussideDrug
Also called Sodium Nitroprusside IV infusion 3 mcg/kg/ min
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS

Study groups in NCT00135668
Study group	Role	What they receive
0.3 mcg/kg/min	Active comparator	Infusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons. Receives: Drug: Nitroprusside
1 mcg/kg/min	Active comparator	Infusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons. Receives: Drug: Nitroprusside
2 mcg/kg/min	Active comparator	Infusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons Receives: Drug: Nitroprusside
3 mcg/kg/min	Active comparator	Infusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons Receives: Drug: Nitroprusside

What is being measured

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

Change in Mean Arterial Pressure (MAP) From the Baseline MAP
From the Baseline MAP until the end of the blinded phase; scheduled for 30 min
Measured: Approximately 30 minutes
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment. Subjects will be followed for 30 days after discontinuation of study drug. The occurrence of Serious Adverse Events (SAEs) will be monitored for 30 days.
Measured: 30 days

Secondary outcomes (3)

Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;
Change From Baseline in MAP (mmHg) After 20 and 25 Minutes Double-Blind Infusion (Overall) for ITT Efficacy Evaluable Population.
Measured: 25 minutes
Infusion Rate of Sodium Nitroprusside That Reduces MAP to a Predetermined Clinically Meaningful Target Value +/- 10%;
Infusion rate of sodium nitroprusside at which a predetermined clinically meaningful target value (+/- 10%) of MAP was achieved during study drug administration
Measured: Up to the end of open label treatment (Approximately 120 minutes)
Number of Participants Who Reach Target MAP;
Blinded Study Drug Administration Period: Started with study drug administration following stabilization of anesthesia. Patients were administered a blinded dose of SNP for up to 30 mins.
This period ended at the start of open-label study drug infusion or at the completion of the blinded infusion if no open-label study drug was given. The follow-up period immediately followed for those patients not receiving open-label infusion.
Blinded Treatment Phase II - gap between the end of blinded study drug infusion and the start of open-label study drug infusion
Open-label treatment phase began with the start of open-label study drug infusion and was at least 90 mins in duration. SNP was initiated at a dose deemed appropriate by the investigator and was gradually adjusted to reach a target MAP based on clinical presentation and needs of the patient. Target MAP was not to be < 50 mmHg (40 mmHg for patients < 30 days of age). This period ended at the completion of open-label infusion.
Measured: To the end of open label treatment (approximately 120 minutes)

Timeline

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

Aug 2005Feb 2009

First posted26 Aug 2005 (estimated)
Study startAug 2005
Primary completionMar 2008
Study completionFeb 2009

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 HypotensionStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00135668
Sponsor's protocol ID: NICHD-2003-09-DR
Other IDs: N01HD43386-7-0-1
Status last verified: Dec 2023
First submitted: 25 Aug 2005
Last updated: 2 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Drover DR, Hammer GB, Barrett JS, Cohane CA, Reece T, Zajicek A, Schulman SR. Evaluation of sodium nitroprusside for controlled hypotension in children during surgery. Front Pharmacol. 2015 Jul 6;6:136. doi: 10.3389/fphar.2015.00136. eCollection 2015.
PubMed 26217225
Hammer GB, Connolly SG, Schulman SR, Lewandowski A, Cohane C, Reece TL, Anand R, Mitchell J, Drover DR. Sodium nitroprusside is not associated with metabolic acidosis during intraoperative infusion in children. BMC Anesthesiol. 2013 Apr 30;13:9. doi: 10.1186/1471-2253-13-9.
PubMed 23631460

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?

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All Hypotension trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel Group, Dose-ranging, Effect-controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside in Pediatric Subjects
ClinicalTrials.gov ID: NCT00135668
Acronym / sponsor ID: NICHD-2003-09-DR
Conditions: Hypotension
Keywords: children, sodium nitroprusside, controlled hypotension, dose-response, pharmacokinetics, pharmacodynamics, safety, efficacy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: The Emmes Company, LLCIndustry (pharma, biotech, devices)
Collaborators: Stanford University, Duke University
Study start: Aug 2005
Primary completion: Mar 2008 (actual)
Study completion: Feb 2009 (actual)
First posted: 26 Aug 2005 (estimated)
Results: Posted 2 Jan 2024

Clinical summary

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

Detailed description

The specific aims of this trial are:

To define the onset and offset of blood pressure lowering effects of nitroprusside to obtain adequate instructions for dose titration in the pediatric population.
To construct a dose-response model that defines the relationship between nitroprusside infusion rate and changes in blood pressure in pediatric subjects.
To assess the safety of nitroprusside administration in pediatric subjects requiring controlled reduction of blood pressure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
0.3 mcg/kg/min	Active comparator	Drug: NitroprussideInfusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons.
1 mcg/kg/min	Active comparator	Drug: NitroprussideInfusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons.
2 mcg/kg/min	Active comparator	Drug: NitroprussideInfusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons
3 mcg/kg/min	Active comparator	Drug: NitroprussideInfusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 of the full rate; and 20 minutes at the full dose rate (ie, 30 minutes total). The full infusion rate was 0.6 mL/kg/hr; 2/3 of the full rate was 0.4 mL/kg/hr; and 1/3 of the full rate was 0.2 mL/kg/hr. After titration to the full dose of blinded study drug, blinded infusion dosage adjustments were not permitted during the blinded study drug administration period. The blinded infusion dosage continued for the 30 minutes unless clinical events demanded a change for safety reasons

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Subject is less than 17 years of age
Neonates must be full-term gestation and have a body weight of at least 2.5 kg
Subject requires pharmacologically-induced hypotension for acute blood pressure management for surgery or other invasive procedure, e.g., cerebral artery embolization
Duration of the subject's controlled hypotension is expected to be ≥ 2 hours
Subject requires general anesthesia with endotracheal intubation

Key exclusion criteria (8 listed)

Subject has a known allergy to SNP
Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes
Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or procedures
Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures

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
NitroprussideAlso: Sodium Nitroprusside IV infusion 0.3 mcg/kg/ minStudy drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS (Interactive Voice Response System).	Drug	0.3 mcg/kg/min
NitroprussideAlso: Sodium Nitroprusside IV infusion 1 mcg/kg/ minStudy drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.	Drug	1 mcg/kg/min
NitroprussideAlso: Sodium Nitroprusside IV infusion 2 mcg/kg/ minStudy drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.	Drug	2 mcg/kg/min
NitroprussideAlso: Sodium Nitroprusside IV infusion 3 mcg/kg/ minStudy drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS	Drug	3 mcg/kg/min

Primary outcome

Change in Mean Arterial Pressure (MAP) From the Baseline MAP
Time frame: Approximately 30 minutes
From the Baseline MAP until the end of the blinded phase; scheduled for 30 min
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
Time frame: 30 days
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment. Subjects will be followed for 30 days after discontinuation of study drug. The occurrence of Serious Adverse Events (SAEs) will be monitored for 30 days.

3 secondary outcomes

Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;
Time frame: 25 minutes
Infusion Rate of Sodium Nitroprusside That Reduces MAP to a Predetermined Clinically Meaningful Target Value +/- 10%;
Time frame: Up to the end of open label treatment (Approximately 120 minutes)
Number of Participants Who Reach Target MAP;
Time frame: To the end of open label treatment (approximately 120 minutes)

Results and safety

Results posted to the registry on 2 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.3 μg/kg/Min	51	50
1 μg/kg/Min	49	49
2 μg/kg/Min	55	53
3 μg/kg/Min	51	51

Primary outcome: Change in Mean Arterial Pressure (MAP) From the Baseline MAP

Time frame: Approximately 30 minutes. Mean (Standard Deviation). Unit: mm Hg

Measure	0.3 mcg/kg/Min n = 50	1 mcg/kg/Min n = 49	2 mcg/kg/Min n = 53	3 mcg/kg/Min n = 51	Total n = 203
Baseline Observed	76.3 (11.37)	76.9 (14.5)	73.5 (11.5)	76.3 (12.06)	75.7 (12.37)
30 Minutes LOCF(last observation carried forward)	65.3 (13.30)	59.9 (15.43)	53.5 (12.09)	59.6 (17.82)	59.5 (15.28)
Change from Baseline	-11.0 (15.68)	-17.0 (12.88)	-20.0 (15.95)	-16.6 (18.63)	-16.2 (16.16)

Total: Mean Difference (Final Values): -16.2 (95% CI -18.44 to -13.97), p <0.001, t-test, 2 sided
0.3 mcg/kg/Min: Mean Difference (Final Values): -11.0 (95% CI -15.45 to -6.55), p <0.001, t-test, 2 sided
1 mcg/kg/Min: Mean Difference (Final Values): -17.0 (95% CI -20.70 to -13.30), p <0.001, t-test, 2 sided

Population analysed: Change from Baseline in MAP across the Sodium Nitroprusside (SNP) dose groups by mean at Baseline, 30 mins (LOCF), and change from Baseline for the ITT Efficacy Evaluable Population consisted of randomized and treated patients who had a pre-treatment Baseline MAP and a second MAP determined within 30 mins of study drug infusion at the starting dose

Primary outcome: Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population

Time frame: 30 days. Number. Unit: participants

Measure	0.3 mcg/kg/Min n = 50	1 mcg/kg/Min n = 49	2 mcg/kg/Min n = 53	3 mcg/kg/Min n = 51	Total n = 203
N of participants with at least one TEAE	50	49	53	51	203
N of participants with at least one TESAE	5	4	5	4	18
N with TEAE leading to study drug withdrawal	19	18	13	16	66
N of participants with MILD TEAE	8	10	7	8	33
N of participants with MODERATE TEAE	19	19	20	15	73
N of participants with SEVERE TEAE	23	20	26	28	97
N of participants with probably related TEAE	29	32	40	36	137
N of participants with possibly related TEAE	12	6	2	9	29

Population analysed: ITT Safety Population consisted of all consented and randomized patients who received any amount of study medication

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.3 μg/kg/Min	24 of 50 (48%)	50 of 50 (100%)	Not reported
1 μg/kg/Min	22 of 49 (44.9%)	49 of 49 (100%)	Not reported
2 μg/kg/Min	18 of 53 (34%)	53 of 53 (100%)	Not reported
3 μg/kg/Min	20 of 51 (39.2%)	51 of 51 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26217225Drover DR, Hammer GB, Barrett JS, Cohane CA, Reece T, Zajicek A, Schulman SR. Evaluation of sodium nitroprusside for controlled hypotension in children during surgery. Front Pharmacol. 2015 Jul 6;6:136. doi: 10.3389/fphar.2015.00136. eCollection 2015.
Derived from this study: PubMed 23631460Hammer GB, Connolly SG, Schulman SR, Lewandowski A, Cohane C, Reece TL, Anand R, Mitchell J, Drover DR. Sodium nitroprusside is not associated with metabolic acidosis during intraoperative infusion in children. BMC Anesthesiol. 2013 Apr 30;13:9. doi: 10.1186/1471-2253-13-9.

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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.

Gregory Hammer, MD principal investigator

Stanford University

Scott Schulman, MD principal investigator

Duke University

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nitroprusside in people with Hypotension, run by The Emmes Company, LLC at 1 site in United States.

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 8 inclusion and 8 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 2 Jan 2024. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2024). 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?

Change in Mean Arterial Pressure (MAP) From the Baseline MAP (time frame: Approximately 30 minutes). The study lists 2 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 NCT00135668, 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 2 Jan 2024.