Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial InfarctionHydro-AKINCT07761754
The Effect of Hydration on the Prevention of CI-AKI in STEMI Patients Undergoing Primary PCI (Hydro-AKI Trial)
A study testing oral hydration protocol in people with Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction and Contrast Induced AKI, run by Assiut University.
Trial summary
The goal of this clinical trial is to determine whether a structured oral hydration regimen reduces the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction, Contrast Induced AKI
- What is being tested?
- oral hydration protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All of the following must be present:
- Age ≥18 years at the time of randomization
- Clinical diagnosis of STEMI, confirmed by 12-lead ECG showing ≥30 minutes of ST-segment elevation ≥1 mm in ≥2 contiguous limb leads or ≥2 mm in ≥2 contiguous precordial leads, or new left bundle branch block with a clinical presentation consistent with acute myocardial infarction
- Decision to proceed with primary PCI as the reperfusion strategy, within 12 hours of symptom onset (or up to 24 hours if evidence of persistent ischaemia or haemodynamic instability)
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m², calculated by the CKD-EPI 2021 formula from the most recent available serum creatinine measurement prior to contrast exposure
- Ability to swallow and safely tolerate oral fluids, as assessed by the attending physician
- Oral informed consent obtained from the patient or a legally authorized representative (deferred consent protocol applies in emergencies per IRB approval)
Who cannot join
- - Cardiogenic shock on presentation, defined as systolic blood pressure <90 mmHg for >30 minutes despite fluid resuscitation, or requirement for vasopressor or inotropic therapy to maintain SBP ≥90 mmHg, with evidence of end-organ hypoperfusion (Killip Class IV)
- Acute pulmonary oedema or Killip Class III with SpO₂ <90% on room air, bilateral crepitations >50% of lung fields, or chest X-ray showing pulmonary venous congestion requiring urgent diuresis
- Pre-existing dialysis dependence (haemodialysis or peritoneal dialysis) or eGFR <30 mL/min/1.73m² on admission
- Active vomiting, dysphagia, altered consciousness (GCS <14), or any clinical condition precluding safe oral fluid intake, as assessed by the attending physician
- Administration of any IV hydration protocol for CIN prevention prior to randomization (patients may have received standard IV fluids for other indications; these are documented but do not constitute exclusion unless specifically intended as CIN prophylaxis)
- Known severe allergy to iodinated contrast media that cannot be managed with pre-medication (moderate/mild allergies and prior mild reactions are not exclusions)
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- Concurrent administration of known nephrotoxic agents within 48 hours that cannot be withheld or dose-adjusted: aminoglycoside antibiotics (gentamicin, amikacin), high-dose loop diuretics in the context of diuretic nephropathy, or cisplatin-based chemotherapy
- Pregnancy (confirmed by urine or serum beta-hCG) or active breastfeeding
- Estimated life expectancy <30 days from a non-cardiac cause (advanced malignancy, end-stage liver disease, multiorgan failure)
About this study
Official title: The Effect of Hydration on the Prevention of Contrast Induced Acute Kidney Injury (CI-AKI) in ST Segment Elevation Myocardial Infarction Undergoing Primary PCI (Hydro-AKI Trial)
The goal of this clinical trial is to determine whether a structured oral hydration regimen reduces the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). The main questions it aims to answer are:
Does a structured oral hydration regimen reduce the incidence of CI-AKI compared with standard care without a prescribed hydration regimen? Does oral hydration improve renal outcomes without increasing the risk of adverse events, such as heart failure or fluid overload, in patients undergoing PPCI?
Read more
Researchers will compare patients receiving a structured oral hydration regimen with patients receiving standard care without a prescribed hydration regimen to determine whether oral hydration decreases the incidence of CI-AKI and improves clinical outcomes.
Participants will:
Be randomly assigned to either the oral hydration group or the standard care group.
Undergo primary percutaneous coronary intervention according to institutional practice.
Receive the assigned hydration strategy after the procedure. Have serum creatinine measured at baseline and after contrast exposure to assess for CI-AKI.
Be monitored for adverse events, including fluid overload, heart failure, need for renal replacement therapy, length of hospital stay, and other relevant clinical outcomes.
Read the detailed description
Contrast-induced acute kidney injury (CI-AKI) remains one of the most common complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The development of CI-AKI is associated with prolonged hospitalization, increased healthcare costs, higher rates of cardiovascular complications, and increased short- and long-term mortality. Despite advances in interventional cardiology, effective preventive strategies for CI-AKI in the emergency PPCI setting remain limited.
Adequate hydration is considered the cornerstone of CI-AKI prevention because it improves renal perfusion, suppresses vasoconstrictive mechanisms, dilutes intratubular contrast media, and promotes urinary excretion of contrast agents. However, the evidence supporting hydration strategies has been derived primarily from elective coronary procedures, where patients can receive intravenous hydration before and after contrast administration. In STEMI patients undergoing PPCI, the urgent nature of treatment often precludes pre-procedural hydration, and aggressive intravenous fluid administration may increase the risk of volume overload in patients with impaired cardiac function.
Oral hydration represents a simple, inexpensive, and widely accessible alternative that may offer renal protection while minimizing the logistical challenges associated with intravenous hydration in the acute setting. However, evidence regarding its effectiveness in patients undergoing emergency PPCI remains scarce, particularly in low- and middle-income countries.
This prospective, randomized, controlled clinical trial is designed to evaluate whether a structured oral hydration regimen initiated after PPCI reduces the incidence of CI-AKI compared with standard care without a prescribed hydration regimen. Eligible adult patients presenting with STEMI and undergoing successful PPCI will be randomly assigned in a 1:1 ratio to receive either the oral hydration protocol or standard care. All participants will receive routine evidence-based management for STEMI according to current institutional practice and contemporary clinical guidelines.
Renal function will be assessed using serum creatinine measurements obtained at baseline and after contrast exposure. CI-AKI will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Participants will also be monitored for safety outcomes, including signs and symptoms of heart failure or fluid overload, as well as clinically relevant in-hospital outcomes. Additional analyses will evaluate the relationship between oral hydration adherence and renal outcomes.
The primary outcome is the incidence of CI-AKI following PPCI. Secondary outcomes include changes in renal function, requirement for renal replacement therapy, duration of hospitalization, major in-hospital adverse clinical events, and safety outcomes related to hydration therapy.
The findings of this study are expected to provide evidence regarding the effectiveness and safety of structured oral hydration as a practical, low-cost preventive strategy for CI-AKI in patients with STEMI undergoing primary PCI, particularly in resource-limited healthcare settings.
- Conditions
- Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction, Contrast Induced AKI
- Being tested
- oral hydration protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral hydration protocolOther
The intervention consists of a standardized, nurse-supported oral hydration protocol with a target intake of at least 1,500 mL within 12 hours surrounding primary percutaneous coronary intervention (PPCI). Unlike routine care, participants receive scheduled hydration targets, standardized documentation of fluid intake, nursing reinforcement to optimize adherence, and verification of protocol completion by the research coordinator. This structured approach is designed to provide a consistent, practical, and low-cost hydration strategy for the prevention of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI).
| Study group | Role | What they receive |
|---|---|---|
| Structured Oral Hydration , Arm 1 | Active comparator | Participants randomized to the intervention arm will receive a structured oral hydration regimen in addition to standard medical care. The protocol consists of a target oral fluid intake of at least 1,500 mL within 12 hours of primary percutaneous coronary intervention (PPCI), including 500 mL of plain water 30-60 minutes before arterial sheath insertion, 500 mL of water within the first 4 hours after sheath removal, and at least 500 mL of water during 4-12 hours after the procedure. Oral fluid intake will be encouraged by nursing staff, documented on a standardized fluid intake chart, and reviewed by the research coordinator at the 12-hour time point. Participants will otherwise receive standard guideline-directed care for STEMI. Receives: Other: oral hydration protocol |
| Standard Care / No Prescribed Oral Hydration Regimen (control arm) | No intervention | Participants randomized to the control arm will receive standard medical care for ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) according to institutional practice. No structured oral hydration regimen will be prescribed. Oral fluid intake will be permitted according to routine clinical care and at the discretion of the treating healthcare team. All other aspects of patient management, including medications, monitoring, and follow-up, will be provided in accordance with current institutional protocols and clinical guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast-induced acute kidney injury (CI-AKI)
Incidence of CI-AKI, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days after contrast exposure.
Measured: Within 48 hours after primary percutaneous coronary intervention (PPCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Khaled Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761754
- Sponsor's protocol ID
- hydration & preventing CI-AKI
- Acronym
- Hydro-AKI
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Demirtola AI, Mammadli A, Cicek G. Triglyceride-glucose index as a predictor of contrast-induced nephropathy in nondiabetic patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention: a retrospective study. Coron Artery Dis. 2025 Jun 1;36(4):326-332. doi: 10.1097/MCA.0000000000001524. Epub 2025 Apr 29.
PubMed 40153007Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
PubMed 22890468Liu L, Yuan Z, Ning X, Wang J, Li Y, Song X, Zhang F. The predictive value of triglyceride glucose-body mass index for contrast-induced nephropathy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Sci Rep. 2025 Jul 1;15(1):21051. doi: 10.1038/s41598-025-07212-1.
PubMed 40595003Pioli MR, Couto RM, Francisco JA, Antoniassi DQ, Souza CR, Olivio MY, Anhe GF, Giopatto S, Sposito AC, Nadruz W, Coelho-Filho OR, Modolo R. Effectiveness of Oral Hydration in Preventing Contrast-Induced Nephropathy in Individuals Undergoing Elective Coronary Interventions. Arq Bras Cardiol. 2023 Feb 27;120(2):e20220529. doi: 10.36660/abc.20220529. eCollection 2023. English, Portuguese.
PubMed 36856244Javid M, Mirdamadi A, Javid M, Amini-Salehi E, Vakilpour A, Keivanlou MH, Porteghali P, Hassanipour S. Gamma glutamyl transferase as a biomarker to predict contrast-induced nephropathy among patients with acute coronary syndrome undergoing coronary interventions: a meta-analysis. Ann Med Surg (Lond). 2023 Jun 20;85(8):4033-4040. doi: 10.1097/MS9.0000000000000967. eCollection 2023 Aug.
PubMed 37554858He H, Chen XR, Chen YQ, Niu TS, Liao YM. Prevalence and Predictors of Contrast-Induced Nephropathy (CIN) in Patients with ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI): A Meta-Analysis. J Interv Cardiol. 2019 Aug 25;2019:2750173. doi: 10.1155/2019/2750173. eCollection 2019.
PubMed 31772520Luo E, Wang D, Yan G, Qiao Y, Liu B, Hou J, Tang C. High triglyceride-glucose index is associated with poor prognosis in patients with acute ST-elevation myocardial infarction after percutaneous coronary intervention. Cardiovasc Diabetol. 2019 Nov 13;18(1):150. doi: 10.1186/s12933-019-0957-3.
PubMed 31722708Kiris T, Avci E, Celik A. Association of the blood urea nitrogen-to-left ventricular ejection fraction ratio with contrast-induced nephropathy in patients with acute coronary syndrome who underwent percutaneous coronary intervention. Int Urol Nephrol. 2019 Mar;51(3):475-481. doi: 10.1007/s11255-018-2052-1. Epub 2019 Jan 2.
PubMed 30604231Gursoy E, Baydar O. The triglyceride-glucose index and contrast-induced nephropathy in non-ST elevation myocardial infarction patients undergoing percutaneous coronary intervention. Medicine (Baltimore). 2023 Jan 13;102(2):e32629. doi: 10.1097/MD.0000000000032629.
PubMed 36637929Chang WT, Sun CK, Wu JY, Huang PY, Liu TH, Chang YJ, Lin YT, Kang FC, Hung KC. Association of prognostic nutritional index with risk of contrast induced nephropathy: A meta-analysis. Front Nutr. 2023 Mar 23;10:1154409. doi: 10.3389/fnut.2023.1154409. eCollection 2023.
PubMed 37032787Karauzum I, Karauzum K, Hanci K, Gokcek D, Kalas B, Ural E. The Utility of Systemic Immune-Inflammation Index for Predicting Contrast-Induced Nephropathy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Cardiorenal Med. 2022;12(2):71-80. doi: 10.1159/000524945. Epub 2022 May 17.
PubMed 35580559Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
PubMed 15464318Persson PB, Hansell P, Liss P. Pathophysiology of contrast medium-induced nephropathy. Kidney Int. 2005 Jul;68(1):14-22. doi: 10.1111/j.1523-1755.2005.00377.x.
PubMed 15954892McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr 15;51(15):1419-28. doi: 10.1016/j.jacc.2007.12.035.
PubMed 18402894Rear R, Bell RM, Hausenloy DJ. Contrast-induced nephropathy following angiography and cardiac interventions. Heart. 2016 Apr;102(8):638-48. doi: 10.1136/heartjnl-2014-306962. Epub 2016 Feb 8. No abstract available.
PubMed 26857214
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydration on the Prevention of Contrast Induced Acute Kidney Injury (CI-AKI) in ST Segment Elevation Myocardial Infarction Undergoing Primary PCI (Hydro-AKI Trial)
- ClinicalTrials.gov ID
- NCT07761754
- Acronym / sponsor ID
- Hydro-AKI / hydration & preventing CI-AKI
- Conditions
- Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction, Contrast Induced AKI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 12 Aug 2026 (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.
The goal of this clinical trial is to determine whether a structured oral hydration regimen reduces the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). The main questions it aims to answer are:
Does a structured oral hydration regimen reduce the incidence of CI-AKI compared with standard care without a prescribed hydration regimen? Does oral hydration improve renal outcomes without increasing the risk of adverse events, such as heart failure or fluid overload, in patients undergoing PPCI?
Researchers will compare patients receiving a structured oral hydration regimen with patients receiving standard care without a prescribed hydration regimen to determine whether oral hydration decreases the incidence of CI-AKI and improves clinical outcomes.
Participants will:
Be randomly assigned to either the oral hydration group or the standard care group.
Undergo primary percutaneous coronary intervention according to institutional practice.
Receive the assigned hydration strategy after the procedure. Have serum creatinine measured at baseline and after contrast exposure to assess for CI-AKI.
Be monitored for adverse events, including fluid overload, heart failure, need for renal replacement therapy, length of hospital stay, and other relevant clinical outcomes.
Detailed description
Contrast-induced acute kidney injury (CI-AKI) remains one of the most common complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The development of CI-AKI is associated with prolonged hospitalization, increased healthcare costs, higher rates of cardiovascular complications, and increased short- and long-term mortality. Despite advances in interventional cardiology, effective preventive strategies for CI-AKI in the emergency PPCI setting remain limited.
Adequate hydration is considered the cornerstone of CI-AKI prevention because it improves renal perfusion, suppresses vasoconstrictive mechanisms, dilutes intratubular contrast media, and promotes urinary excretion of contrast agents. However, the evidence supporting hydration strategies has been derived primarily from elective coronary procedures, where patients can receive intravenous hydration before and after contrast administration. In STEMI patients undergoing PPCI, the urgent nature of treatment often precludes pre-procedural hydration, and aggressive intravenous fluid administration may increase the risk of volume overload in patients with impaired cardiac function.
Oral hydration represents a simple, inexpensive, and widely accessible alternative that may offer renal protection while minimizing the logistical challenges associated with intravenous hydration in the acute setting. However, evidence regarding its effectiveness in patients undergoing emergency PPCI remains scarce, particularly in low- and middle-income countries.
This prospective, randomized, controlled clinical trial is designed to evaluate whether a structured oral hydration regimen initiated after PPCI reduces the incidence of CI-AKI compared with standard care without a prescribed hydration regimen. Eligible adult patients presenting with STEMI and undergoing successful PPCI will be randomly assigned in a 1:1 ratio to receive either the oral hydration protocol or standard care. All participants will receive routine evidence-based management for STEMI according to current institutional practice and contemporary clinical guidelines.
Renal function will be assessed using serum creatinine measurements obtained at baseline and after contrast exposure. CI-AKI will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Participants will also be monitored for safety outcomes, including signs and symptoms of heart failure or fluid overload, as well as clinically relevant in-hospital outcomes. Additional analyses will evaluate the relationship between oral hydration adherence and renal outcomes.
The primary outcome is the incidence of CI-AKI following PPCI. Secondary outcomes include changes in renal function, requirement for renal replacement therapy, duration of hospitalization, major in-hospital adverse clinical events, and safety outcomes related to hydration therapy.
The findings of this study are expected to provide evidence regarding the effectiveness and safety of structured oral hydration as a practical, low-cost preventive strategy for CI-AKI in patients with STEMI undergoing primary PCI, particularly in resource-limited healthcare settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Oral Hydration , Arm 1 | Active comparator | Other: oral hydration protocolParticipants randomized to the intervention arm will receive a structured oral hydration regimen in addition to standard medical care. The protocol consists of a target oral fluid intake of at least 1,500 mL within 12 hours of primary percutaneous coronary intervention (PPCI), including 500 mL of plain water 30-60 minutes before arterial sheath insertion, 500 mL of water within the first 4 hours after sheath removal, and at least 500 mL of water during 4-12 hours after the procedure. Oral fluid intake will be encouraged by nursing staff, documented on a standardized fluid intake chart, and reviewed by the research coordinator at the 12-hour time point. Participants will otherwise receive standard guideline-directed care for STEMI. |
| Standard Care / No Prescribed Oral Hydration Regimen (control arm) | No intervention | –Participants randomized to the control arm will receive standard medical care for ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) according to institutional practice. No structured oral hydration regimen will be prescribed. Oral fluid intake will be permitted according to routine clinical care and at the discretion of the treating healthcare team. All other aspects of patient management, including medications, monitoring, and follow-up, will be provided in accordance with current institutional protocols and clinical guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years at the time of randomization
- Clinical diagnosis of STEMI, confirmed by 12-lead ECG showing ≥30 minutes of ST-segment elevation ≥1 mm in ≥2 contiguous limb leads or ≥2 mm in ≥2 contiguous precordial leads, or new left bundle branch block with a clinical presentation consistent with acute myocardial infarction
- Decision to proceed with primary PCI as the reperfusion strategy, within 12 hours of symptom onset (or up to 24 hours if evidence of persistent ischaemia or haemodynamic instability)
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m², calculated by the CKD-EPI 2021 formula from the most recent available serum creatinine measurement prior to contrast exposure
- Ability to swallow and safely tolerate oral fluids, as assessed by the attending physician
Key exclusion criteria (9 listed)
- - Cardiogenic shock on presentation, defined as systolic blood pressure <90 mmHg for >30 minutes despite fluid resuscitation, or requirement for vasopressor or inotropic therapy to maintain SBP ≥90 mmHg, with evidence of end-organ hypoperfusion (Killip Class IV)
- Acute pulmonary oedema or Killip Class III with SpO₂ <90% on room air, bilateral crepitations >50% of lung fields, or chest X-ray showing pulmonary venous congestion requiring urgent diuresis
- Pre-existing dialysis dependence (haemodialysis or peritoneal dialysis) or eGFR <30 mL/min/1.73m² on admission
- Active vomiting, dysphagia, altered consciousness (GCS <14), or any clinical condition precluding safe oral fluid intake, as assessed by the attending physician
- Administration of any IV hydration protocol for CIN prevention prior to randomization (patients may have received standard IV fluids for other indications; these are documented but do not constitute exclusion unless specifically intended as CIN prophylaxis)
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 |
|---|---|---|
| oral hydration protocolThe intervention consists of a standardized, nurse-supported oral hydration protocol with a target intake of at least 1,500 mL within 12 hours surrounding primary percutaneous coronary intervention (PPCI). Unlike routine care, participants receive scheduled hydration targets, standardized documentation of fluid intake, nursing reinforcement to optimize adherence, and verification of protocol completion by the research coordinator. This structured approach is designed to provide a consistent, practical, and low-cost hydration strategy for the prevention of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI). | Other | Structured Oral Hydration , Arm 1 |
Primary outcome
Incidence of contrast-induced acute kidney injury (CI-AKI)
Time frame: Within 48 hours after primary percutaneous coronary intervention (PPCI)
Incidence of CI-AKI, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days after contrast exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 40153007Demirtola AI, Mammadli A, Cicek G. Triglyceride-glucose index as a predictor of contrast-induced nephropathy in nondiabetic patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention: a retrospective study. Coron Artery Dis. 2025 Jun 1;36(4):326-332. doi: 10.1097/MCA.0000000000001524. Epub 2025 Apr 29.
- Background: PubMed 22890468Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
- Background: PubMed 40595003Liu L, Yuan Z, Ning X, Wang J, Li Y, Song X, Zhang F. The predictive value of triglyceride glucose-body mass index for contrast-induced nephropathy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Sci Rep. 2025 Jul 1;15(1):21051. doi: 10.1038/s41598-025-07212-1.
- Background: PubMed 36856244Pioli MR, Couto RM, Francisco JA, Antoniassi DQ, Souza CR, Olivio MY, Anhe GF, Giopatto S, Sposito AC, Nadruz W, Coelho-Filho OR, Modolo R. Effectiveness of Oral Hydration in Preventing Contrast-Induced Nephropathy in Individuals Undergoing Elective Coronary Interventions. Arq Bras Cardiol. 2023 Feb 27;120(2):e20220529. doi: 10.36660/abc.20220529. eCollection 2023. English, Portuguese.
- Background: PubMed 37554858Javid M, Mirdamadi A, Javid M, Amini-Salehi E, Vakilpour A, Keivanlou MH, Porteghali P, Hassanipour S. Gamma glutamyl transferase as a biomarker to predict contrast-induced nephropathy among patients with acute coronary syndrome undergoing coronary interventions: a meta-analysis. Ann Med Surg (Lond). 2023 Jun 20;85(8):4033-4040. doi: 10.1097/MS9.0000000000000967. eCollection 2023 Aug.
- Background: PubMed 31772520He H, Chen XR, Chen YQ, Niu TS, Liao YM. Prevalence and Predictors of Contrast-Induced Nephropathy (CIN) in Patients with ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Percutaneous Coronary Intervention (PCI): A Meta-Analysis. J Interv Cardiol. 2019 Aug 25;2019:2750173. doi: 10.1155/2019/2750173. eCollection 2019.
- Background: PubMed 31722708Luo E, Wang D, Yan G, Qiao Y, Liu B, Hou J, Tang C. High triglyceride-glucose index is associated with poor prognosis in patients with acute ST-elevation myocardial infarction after percutaneous coronary intervention. Cardiovasc Diabetol. 2019 Nov 13;18(1):150. doi: 10.1186/s12933-019-0957-3.
- Background: PubMed 30604231Kiris T, Avci E, Celik A. Association of the blood urea nitrogen-to-left ventricular ejection fraction ratio with contrast-induced nephropathy in patients with acute coronary syndrome who underwent percutaneous coronary intervention. Int Urol Nephrol. 2019 Mar;51(3):475-481. doi: 10.1007/s11255-018-2052-1. Epub 2019 Jan 2.
- Background: PubMed 36637929Gursoy E, Baydar O. The triglyceride-glucose index and contrast-induced nephropathy in non-ST elevation myocardial infarction patients undergoing percutaneous coronary intervention. Medicine (Baltimore). 2023 Jan 13;102(2):e32629. doi: 10.1097/MD.0000000000032629.
- Background: PubMed 37032787Chang WT, Sun CK, Wu JY, Huang PY, Liu TH, Chang YJ, Lin YT, Kang FC, Hung KC. Association of prognostic nutritional index with risk of contrast induced nephropathy: A meta-analysis. Front Nutr. 2023 Mar 23;10:1154409. doi: 10.3389/fnut.2023.1154409. eCollection 2023.
- Background: PubMed 35580559Karauzum I, Karauzum K, Hanci K, Gokcek D, Kalas B, Ural E. The Utility of Systemic Immune-Inflammation Index for Predicting Contrast-Induced Nephropathy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Cardiorenal Med. 2022;12(2):71-80. doi: 10.1159/000524945. Epub 2022 May 17.
- Background: PubMed 15464318Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
Related trials for Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing oral hydration protocol in people with Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction and Contrast Induced AKI, run by Assiut University.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 contrast-induced acute kidney injury (CI-AKI) (time frame: Within 48 hours after primary percutaneous coronary intervention (PPCI)). 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 NCT07761754, which also lists 16 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 8 Sep 2026.