Shock, SurgicalPhase 4NCT04529005

Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients

A Phase 4 study testing Angiotensin II in people with Shock, Surgical and Shock, run by University of Illinois Chicago 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Shock, Surgical, Shock, Hypotension and Shock
What is being tested?: Angiotensin II
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 13 Aug 2020to 1 Aug 2021
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients > 18 years of age
Receiving deceased donor kidney transplant
Pre-transplant Ejection Fraction (within past 18 months) > 50%
Intraoperative or postoperative distributive shock (according to hospital and study protocol) requiring vasopressor support

Who cannot join

Pregnant patients (they would be excluded from receiving a transplant)
Prisoners
History of mesenteric ischemia
History of aortic dissection
History of abdominal aortic aneurysm
Allergy to mannitol
Absolute neutrophil count < 1000 cell/mm3 (within past 18 months)
Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant

The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.

Conditions: Shock, Surgical, Shock, Hypotension and Shock, Kidney Transplant; Complications, Intraoperative Hypotension, Postoperative Hypotension
Being tested: Angiotensin II
Medical subject headings: Shock, Surgical, Shock, Hypotension

What participants receive

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

Angiotensin IIDrug
If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.

Study groups in NCT04529005
Study group	Role	What they receive
Angiotensin II (Giapreza)	Experimental	Not described Receives: Drug: Angiotensin II

What is being measured

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

Duration of ATII Vasopressor Usage in the Intraoperative Setting
Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.
Measured: Duration of usage during the transplant surgery - presented in hours

Secondary outcomes (6)

Number (and Percentage) of Patients With Arrhythmias
The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.
Measured: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Peripheral/Visceral Ischemia
The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.
Measured: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Thrombosis
Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)
Measured: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Fungal Infections
The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.
Measured: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Hyperglycemia
The presence of hyperglycemia was captured for each patient and was determined by those patients requiring the use of an insulin infusion after their transplant surgery.
Measured: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Delayed Graft Function
The presence of Delayed Graft Function was captured for each patient and defined by the need for renal replacement therapy up to 7 days post-operative.
Measured: From post-op to 7 days post-op

Timeline

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

13 Aug 20201 Aug 2021

First posted27 Aug 2020
Study start13 Aug 2020
Primary completion1 Aug 2021
Study completion1 Aug 2021

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 (12)Papers the sponsor has linked to this study.
Other trials for Shock, SurgicalStudies of the same condition, open and under way.
More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04529005
Sponsor's protocol ID: 2020-0526
Status last verified: Nov 2022
First submitted: 14 Aug 2020
Last updated: 21 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144.
PubMed 25948896
Busse LW, Ostermann M. Vasopressor Therapy and Blood Pressure Management in the Setting of Acute Kidney Injury. Semin Nephrol. 2019 Sep;39(5):462-472. doi: 10.1016/j.semnephrol.2019.06.006.
PubMed 31514910
Campos L, Parada B, Furriel F, Castelo D, Moreira P, Mota A. Do intraoperative hemodynamic factors of the recipient influence renal graft function? Transplant Proc. 2012 Jul-Aug;44(6):1800-3. doi: 10.1016/j.transproceed.2012.05.042.
PubMed 22841277
Day KM, Beckman RM, Machan JT, Morrissey PE. Efficacy and safety of phenylephrine in the management of low systolic blood pressure after renal transplantation. J Am Coll Surg. 2014 Jun;218(6):1207-13. doi: 10.1016/j.jamcollsurg.2014.01.058. Epub 2014 Mar 12.
PubMed 24768292
Choi JM, Jo JY, Baik JW, Kim S, Kim CS, Jeong SM. Risk factors and outcomes associated with a higher use of inotropes in kidney transplant recipients. Medicine (Baltimore). 2017 Jan;96(1):e5820. doi: 10.1097/MD.0000000000005820.
PubMed 28072739
Ciapetti M, di Valvasone S, di Filippo A, Cecchi A, Bonizzoli M, Peris A. Low-dose dopamine in kidney transplantation. Transplant Proc. 2009 Dec;41(10):4165-8. doi: 10.1016/j.transproceed.2009.08.058.
PubMed 20005360
Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.
PubMed 28528561
Lankadeva YR, Kosaka J, Evans RG, Bellomo R, May CN. Urinary Oxygenation as a Surrogate Measure of Medullary Oxygenation During Angiotensin II Therapy in Septic Acute Kidney Injury. Crit Care Med. 2018 Jan;46(1):e41-e48. doi: 10.1097/CCM.0000000000002797.
PubMed 29077618
Robert R, Guilhot J, Pinsard M, Longeard PL, Jacob JP, Gissot V, Hauet T, Seguin F. A pair analysis of the delayed graft function in kidney recipient: the critical role of the donor. J Crit Care. 2010 Dec;25(4):582-90. doi: 10.1016/j.jcrc.2010.02.011. Epub 2010 Apr 8.
PubMed 20381298
Toth M, Reti V, Gondos T. Effect of recipients' peri-operative parameters on the outcome of kidney transplantation. Clin Transplant. 1998 Dec;12(6):511-7.
PubMed 9850443
Tumlin JA, Murugan R, Deane AM, Ostermann M, Busse LW, Ham KR, Kashani K, Szerlip HM, Prowle JR, Bihorac A, Finkel KW, Zarbock A, Forni LG, Lynch SJ, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Bellomo R; Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) Investigators. Outcomes in Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with Intravenous Angiotensin II. Crit Care Med. 2018 Jun;46(6):949-957. doi: 10.1097/CCM.0000000000003092.
PubMed 29509568
Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589

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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Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant
ClinicalTrials.gov ID: NCT04529005
Acronym / sponsor ID: 2020-0526
Conditions: Shock, Surgical, Shock, Hypotension and Shock, Kidney Transplant; Complications, Intraoperative Hypotension, Postoperative Hypotension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of Illinois ChicagoUniversity, hospital or other
Collaborators: La Jolla Pharmaceutical Company
Study start: 13 Aug 2020 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 1 Aug 2021 (actual)
First posted: 27 Aug 2020 (actual)
Results: Posted 21 Dec 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Angiotensin II (Giapreza)	Experimental	Drug: Angiotensin II

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patients > 18 years of age
Receiving deceased donor kidney transplant
Pre-transplant Ejection Fraction (within past 18 months) > 50%
Intraoperative or postoperative distributive shock (according to hospital and study protocol) requiring vasopressor support

Key exclusion criteria (8 listed)

Pregnant patients (they would be excluded from receiving a transplant)
Prisoners
History of mesenteric ischemia
History of aortic dissection
History of abdominal aortic aneurysm

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
Angiotensin IIIf intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.	Drug	Angiotensin II (Giapreza)

Primary outcome

Duration of ATII Vasopressor Usage in the Intraoperative Setting
Time frame: Duration of usage during the transplant surgery - presented in hours
Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.

6 secondary outcomes

Number (and Percentage) of Patients With Arrhythmias
Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Peripheral/Visceral Ischemia
Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Thrombosis
Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Fungal Infections
Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Hyperglycemia
Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.
Number (and Percentage) of Patients With Delayed Graft Function
Time frame: From post-op to 7 days post-op

Results and safety

Results posted to the registry on 21 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Angiotensin II (Giapreza)	20	20

Primary outcome: Duration of ATII Vasopressor Usage in the Intraoperative Setting

Time frame: Duration of usage during the transplant surgery - presented in hours. Median (Inter-Quartile Range). Unit: hours

Measure	Angiotensin II (Giapreza) n = 16
Value	1 (0.5 to 2)

Population analysed: Started ATII intraoperatively

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Angiotensin II (Giapreza)	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25948896Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144.
Background: PubMed 31514910Busse LW, Ostermann M. Vasopressor Therapy and Blood Pressure Management in the Setting of Acute Kidney Injury. Semin Nephrol. 2019 Sep;39(5):462-472. doi: 10.1016/j.semnephrol.2019.06.006.
Background: PubMed 22841277Campos L, Parada B, Furriel F, Castelo D, Moreira P, Mota A. Do intraoperative hemodynamic factors of the recipient influence renal graft function? Transplant Proc. 2012 Jul-Aug;44(6):1800-3. doi: 10.1016/j.transproceed.2012.05.042.
Background: PubMed 24768292Day KM, Beckman RM, Machan JT, Morrissey PE. Efficacy and safety of phenylephrine in the management of low systolic blood pressure after renal transplantation. J Am Coll Surg. 2014 Jun;218(6):1207-13. doi: 10.1016/j.jamcollsurg.2014.01.058. Epub 2014 Mar 12.
Background: PubMed 28072739Choi JM, Jo JY, Baik JW, Kim S, Kim CS, Jeong SM. Risk factors and outcomes associated with a higher use of inotropes in kidney transplant recipients. Medicine (Baltimore). 2017 Jan;96(1):e5820. doi: 10.1097/MD.0000000000005820.
Background: PubMed 20005360Ciapetti M, di Valvasone S, di Filippo A, Cecchi A, Bonizzoli M, Peris A. Low-dose dopamine in kidney transplantation. Transplant Proc. 2009 Dec;41(10):4165-8. doi: 10.1016/j.transproceed.2009.08.058.
Background: PubMed 28528561Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.
Background: PubMed 29077618Lankadeva YR, Kosaka J, Evans RG, Bellomo R, May CN. Urinary Oxygenation as a Surrogate Measure of Medullary Oxygenation During Angiotensin II Therapy in Septic Acute Kidney Injury. Crit Care Med. 2018 Jan;46(1):e41-e48. doi: 10.1097/CCM.0000000000002797.
Background: PubMed 20381298Robert R, Guilhot J, Pinsard M, Longeard PL, Jacob JP, Gissot V, Hauet T, Seguin F. A pair analysis of the delayed graft function in kidney recipient: the critical role of the donor. J Crit Care. 2010 Dec;25(4):582-90. doi: 10.1016/j.jcrc.2010.02.011. Epub 2010 Apr 8.
Background: PubMed 9850443Toth M, Reti V, Gondos T. Effect of recipients' peri-operative parameters on the outcome of kidney transplantation. Clin Transplant. 1998 Dec;12(6):511-7.
Background: PubMed 29509568Tumlin JA, Murugan R, Deane AM, Ostermann M, Busse LW, Ham KR, Kashani K, Szerlip HM, Prowle JR, Bihorac A, Finkel KW, Zarbock A, Forni LG, Lynch SJ, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Bellomo R; Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) Investigators. Outcomes in Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with Intravenous Angiotensin II. Crit Care Med. 2018 Jun;46(6):949-957. doi: 10.1097/CCM.0000000000003092.
Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
Individual participant dataSharing planned: No

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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.

Scott T Benken, PharmD principal investigator

Clinical Associate Professor

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Angiotensin II in people with Shock, Surgical and Shock, run by University of Illinois Chicago 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 4 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 21 Dec 2022. 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 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?

Yes. Results are posted in the registry (first posted 21 Dec 2022). 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?

Duration of ATII Vasopressor Usage in the Intraoperative Setting (time frame: Duration of usage during the transplant surgery - presented in hours). 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 NCT04529005, which also lists 12 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 21 Dec 2022.