Post Induction HypotensionNCT07022730
Prophylactic Noradrenaline Infusion and Its Impact on Post-induction Hypotension
A study testing Noradrenaline 0.2 mcg/kg/min at 5 minutes before induction in people with Post Induction Hypotension and Sepsis, run by Cairo University at 1 site in Egypt.
Trial summary
researchers aim to evaluate the influence of prophylactic noradrenaline infusion on post-induction hypotension Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post Induction Hypotension, Sepsis
- What is being tested?
- Noradrenaline 0.2 mcg/kg/min at 5 minutes before induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2025to 17 Sep 2025
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with sepsis undergoing source control surgery.
Who cannot join
- Patient refusal
- Patient with cardiac pathology ( ischemic heart disease or heart failure)
- Preoperative hemodynamic instability (defined as MAP < 65 mmHg)
- Rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Novel Use of Prophylactic Noradrenaline Infusion and Its Impact on Post-induction Hypotension in Patients With Surgical Sepsis, a Double Blind Randomized Controlled Trial
researchers aim to evaluate the influence of prophylactic noradrenaline infusion on post-induction hypotension
Read the detailed description
If post-induction hypotension is not addressed promptly, it can lead to severe complications such as reduced blood flow, acute kidney damage, and myocardial ischemia. As a result, early detection and proactive intervention are crucial. Researchers of the current study decided to investigate impact of noradrenaline administered as a prophylaxis on post induction hypotension
- Conditions
- Post Induction Hypotension, Sepsis
- Being tested
- Noradrenaline 0.2 mcg/kg/min at 5 minutes before induction
- Keywords
- Hypotension, noradrenaline, sepsis
- Medical subject headings
- Sepsis, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noradrenaline 0.2 mcg/kg/min at 5 minutes before inductionDrug
noradrenaline will be given at a rate of 0.2 mcg/kg/min that will start 5 minutes before induction
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline | Active comparator | Noradrenaline will be infused at a fixed rate of 0.2 mic/kg/min at 5 minutes before induction Receives: Drug: Noradrenaline 0.2 mcg/kg/min at 5 minutes before induction |
| Control | No intervention | Patients will receive normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post induction hypotension in both groups
Hypotension will be considered if MAP< 65 mmHg
Measured: Within the first 10 minutes of induction.
Secondary outcomes (3)
Incidence of acute kidney injury
defined as the highest postoperative value > 1.5-fold or 0.3 mg/dL greater than the preoperative value
Measured: 7 days post operative
Incidence of myocardial infarction
defined as a peak troponin T value exceeding 15 times the normal upper limit, along with new pathological Q waves, ST elevation or depression, and hyperacute T wave on ECG and symptoms suggestive of myocardial infarction
Measured: 7 days postoperative
Incidence of stroke
clinical or image finding of stroke
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start22 Jun 2025
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Induction HypotensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022730
- Sponsor's protocol ID
- noradrenaline and PIH
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared due to privacy concerns, regulatory restrictions, and informed consent limitations.
Publications
Goertz AW, Lindner KH, Seefelder C, Schirmer U, Beyer M, Georgieff M. Effect of phenylephrine bolus administration on global left ventricular function in patients with coronary artery disease and patients with valvular aortic stenosis. Anesthesiology. 1993 May;78(5):834-41. doi: 10.1097/00000542-199305000-00005.
PubMed 8489054Czajka S, Putowski Z, Krzych LJ. Post-induction hypotension and intraoperative hypotension as potential separate risk factors for the adverse outcome: a cohort study. J Anesth. 2023 Jun;37(3):442-450. doi: 10.1007/s00540-023-03191-7. Epub 2023 Apr 21.
PubMed 37083989Tangkulpanich P, Angkoontassaneeyarat C, Trainarongsakul T, Jenpanitpong C. Factors Associated with Postintubation Hypotension Among Patients with Suspected Sepsis in Emergency Department. Open Access Emerg Med. 2023 Nov 14;15:427-436. doi: 10.2147/OAEM.S426822. eCollection 2023.
PubMed 38022743Helmy MA, Mostafa MS, Saber AT, Ali MA, Ismail IA, Naguib BA, Elaraby MM, Milad LM. Preemptive noradrenaline infusion: a game-changer against post-induction hypotension in surgical sepsis: a randomized double blind trial. BMC Anesthesiol. 2026 Apr 11;26(1):236. doi: 10.1186/s12871-026-03783-2.
PubMed 41965525
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Novel Use of Prophylactic Noradrenaline Infusion and Its Impact on Post-induction Hypotension in Patients With Surgical Sepsis, a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07022730
- Acronym / sponsor ID
- noradrenaline and PIH
- Conditions
- Post Induction Hypotension, Sepsis
- Keywords
- Hypotension, noradrenaline, sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
researchers aim to evaluate the influence of prophylactic noradrenaline infusion on post-induction hypotension
Detailed description
If post-induction hypotension is not addressed promptly, it can lead to severe complications such as reduced blood flow, acute kidney damage, and myocardial ischemia. As a result, early detection and proactive intervention are crucial. Researchers of the current study decided to investigate impact of noradrenaline administered as a prophylaxis on post induction hypotension
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline | Active comparator | Drug: Noradrenaline 0.2 mcg/kg/min at 5 minutes before inductionNoradrenaline will be infused at a fixed rate of 0.2 mic/kg/min at 5 minutes before induction |
| Control | No intervention | –Patients will receive normal saline |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with sepsis undergoing source control surgery.
Key exclusion criteria (4 listed)
- Patient refusal
- Patient with cardiac pathology ( ischemic heart disease or heart failure)
- Preoperative hemodynamic instability (defined as MAP < 65 mmHg)
- Rapid sequence induction
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 |
|---|---|---|
| Noradrenaline 0.2 mcg/kg/min at 5 minutes before inductionnoradrenaline will be given at a rate of 0.2 mcg/kg/min that will start 5 minutes before induction | Drug | Noradrenaline |
Primary outcome
Incidence of post induction hypotension in both groups
Time frame: Within the first 10 minutes of induction.
Hypotension will be considered if MAP< 65 mmHg
3 secondary outcomes
Incidence of acute kidney injury
Time frame: 7 days post operative
Incidence of myocardial infarction
Time frame: 7 days postoperative
Incidence of stroke
Time frame: 7 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 8489054Goertz AW, Lindner KH, Seefelder C, Schirmer U, Beyer M, Georgieff M. Effect of phenylephrine bolus administration on global left ventricular function in patients with coronary artery disease and patients with valvular aortic stenosis. Anesthesiology. 1993 May;78(5):834-41. doi: 10.1097/00000542-199305000-00005.
- Results publication: PubMed 37083989Czajka S, Putowski Z, Krzych LJ. Post-induction hypotension and intraoperative hypotension as potential separate risk factors for the adverse outcome: a cohort study. J Anesth. 2023 Jun;37(3):442-450. doi: 10.1007/s00540-023-03191-7. Epub 2023 Apr 21.
- Results publication: PubMed 38022743Tangkulpanich P, Angkoontassaneeyarat C, Trainarongsakul T, Jenpanitpong C. Factors Associated with Postintubation Hypotension Among Patients with Suspected Sepsis in Emergency Department. Open Access Emerg Med. 2023 Nov 14;15:427-436. doi: 10.2147/OAEM.S426822. eCollection 2023.
- Derived from this study: PubMed 41965525Helmy MA, Mostafa MS, Saber AT, Ali MA, Ismail IA, Naguib BA, Elaraby MM, Milad LM. Preemptive noradrenaline infusion: a game-changer against post-induction hypotension in surgical sepsis: a randomized double blind trial. BMC Anesthesiol. 2026 Apr 11;26(1):236. doi: 10.1186/s12871-026-03783-2.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to privacy concerns, regulatory restrictions, and informed consent limitations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noradrenaline 0.2 mcg/kg/min at 5 minutes before induction in people with Post Induction Hypotension and Sepsis, run by Cairo University at 1 site in Egypt.
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 4 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 18 Sep 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of post induction hypotension in both groups (time frame: Within the first 10 minutes of induction.). 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 NCT07022730, which also lists 4 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 18 Sep 2025.