An interventional study of oral hydration protocol in Contrast-Induced Acute Kidney Injury in ST-Segment Elevation Myocardial Infarction and Contrast Induced AKI, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
Among 39 studies in Acute Kidney Injury by Assiut University — 25 open to participants now, 25 under way, none of them phase 3. Acute Kidney Injury · Assiut University.
Among the 39 studies in Acute Kidney Injury by Assiut University, this one is one of 11 that started in 2026, is one of 4 with no phase, reaches primary completion later than 23 of the 24 other live ones, and was the 33rd registered.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 384 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →25 of the 39 studies in Acute Kidney Injury by Assiut University are open now, in 1 country. Each count lists the studies.
Of the 230 Acute Kidney Injury studies recruiting now, 161 (70%) set no upper age limit and 36 (16%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →39 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 11 started in 2026.
Median enrollment 131 across the 4 interventional studies, 100 across the 35 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
9 of the studies in Acute Kidney Injury by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06753409Assiut UniversityProcessed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery | 2026-12-01 |
| NCT07295392Assiut UniversityIs There Any Prognostic Value of Serum Uromodulin in Sepsis Induced AKI. | 2026-12-10 |
| NCT07338734Assiut UniversityFluid Balance in Acute Kidney Injury in Critically Ill Patients | 2027-01 |
| NCT07853911Assiut UniversityPrognostic Value of Stress Hyperglycemia Ratio in Critically Ill Patients | 2027-10 |
| NCT07847125Assiut UniversityUltrasound-Guided Percutaneous Peritoneal Dialysis Catheter Insertion for Urgent-Start Dialysis | 2027-10 |
Among the 39 studies in Acute Kidney Injury by Assiut University, from their registry updates:
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.
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.
Inclusion Criteria:
Inclusion Criteria
All of the following must be present:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: oral hydration protocol
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.
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).
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.
Time frame: Within 48 hours after primary percutaneous coronary intervention (PPCI)
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.
Of 249 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 23 months is below that.
Counting every sponsor, half of 267 studies reached it within 26 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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